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ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ACURATE neo2™ Transfemoral TAVR System
Medtronic CoreValve TAVR System
Edwards SAPIEN 3 TAVR System
ACURATE Prime™ Transfemoral TAVR System XL
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics.

Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation.

  • IC2. Subject has a documented aortic annulus size of ≥21 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device.
  • IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.
  • IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate.
  • IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent.
  • IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
  • IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.

Exclusion Criteria:

  • EC1. Subject has a unicuspid or bicuspid aortic valve.
  • EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
  • EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
  • EC4. Subject is on renal replacement therapy or has eGFR <20.
  • EC5. Subject has a pre-existing prosthetic aortic or mitral valve.
  • EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
  • EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76).
  • EC8. Subject has a need for emergency surgery for any reason.
  • EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
  • EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
  • EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
  • EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions.
  • EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate [PET]).
  • EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
  • EC15. Subject has hypertrophic cardiomyopathy.
  • EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).
  • EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
  • EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
  • EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
  • EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use.
  • EC21. Subject has either of the following:

    • Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
    • Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis.
  • EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
  • EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure.
  • EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
  • EC25. Subject has severe incapacitating dementia.

Additional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below.

  • AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V)
  • AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
  • AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure.

Note: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Banner Good SamaritanRecruiting
  • HonorHealth Scottsdale Healthcare
  • TMC HealthCareRecruiting
  • Baptist Health Medical CenterRecruiting
  • Scripps ClinicRecruiting
  • Kaiser Permanente Los AngelesRecruiting
  • Cedars-Sinai Heart InstituteRecruiting
  • University of California, Davis Medical CenterRecruiting
  • Kaiser Permanente - San Francisco
  • Stanford University Medical Center
  • South Denver Cardiology Associates PC
  • MedStar Washington Hospital CenterRecruiting
  • Morton Plant Hospital
  • Orlando Regional Medical CenterRecruiting
  • Emory University Hospital (Midtown)
  • Piedmont HospitalRecruiting
  • NorthShore University Health Study CoordinatorRecruiting
  • Advocate Christ Medical CenterRecruiting
  • St. John's Hospital (Prairie)
  • St. Vincent's Hospital
  • University of IowaRecruiting
  • Union Memorial HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • University of Massachusetts
  • University of MichiganRecruiting
  • Henry Ford Hospital
  • Abbott Northwestern HospitalRecruiting
  • CentraCare Heart and Vascular CenterRecruiting
  • St. Joseph's Hospital-St. PaulRecruiting
  • Barnes Jewish Hospital
  • Deborah Heart and Lung Center
  • Englewood HealthRecruiting
  • Robert Wood Johnson Medical Center
  • Albany Medical CenterRecruiting
  • Montefiore-Jack D. Weiler HospitalRecruiting
  • Kaleida HealthRecruiting
  • Mount Sinai Medical CenterRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • Cornell Presbyterian - New YorkRecruiting
  • University of North CarolinaRecruiting
  • Carolinas Medical CenterRecruiting
  • Wake Forest University School of Medicine
  • Lindner Center for Research and Education at Christ HospitalRecruiting
  • University Hospitals of ClevelandRecruiting
  • Cleveland ClinicRecruiting
  • Mount Carmel Columbus Cardiology Consultants
  • OhioHealth Research and Innovation InstituteRecruiting
  • Integris Baptist Medical Center
  • Providence Heart InstituteRecruiting
  • Sacred Heart Medical Center - RiverbendRecruiting
  • UPMC - Pinnacle
  • UPMC Pittsburgh
  • LankenauRecruiting
  • WellSpan York HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Lexington Medical Center
  • St Thomas Ascension
  • Austin HeartRecruiting
  • Baylor Heart and Vascular HospitalRecruiting
  • Presbyterian Hospital of DallasRecruiting
  • The Methodist Hospital Research InstituteRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Baylor Regional Medical Center at PlanoRecruiting
  • Methodist Healthcare System of San Antonio dba Methodist HospitalRecruiting
  • The University of Vermont Medical CenterRecruiting
  • University of Virginia Health SystemRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Providence Regional Medical Center
  • Bellin HealthRecruiting
  • Aurora Research InstituteRecruiting
  • Medical College of Wisconsin - Froedtert HospitalRecruiting
  • Royal Columbian HospitalRecruiting
  • Providence Health - St. Paul's HospitalRecruiting
  • London Health Sciences
  • Sunnybrook Health Sciences Centre
  • Centre Hospitalier de l'Universite de Montreal (CHUM)
  • Institut de Cardiologie de Montreal
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Arm Label

ACURATE Valve - Main Randomized

ACURATE Valve - Single-arm Roll-in

Commercial Valve - Main Randomized

ACURATE Valve - Single-arm Prime XL

ACURATE Valve - Extended Durability Randomized

Commercial Valve - Extended Durability Randomized

ACURATE Valve - Continued Access Study

Arm Description

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.

Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL. *50 subjects will be enrolled in the Prime™ XL Nested Registry

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.

Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.

Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.

Outcomes

Primary Outcome Measures

Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.
Primary Effectiveness Endpoint; A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death and stroke to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2018
Last Updated
October 13, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03735667
Brief Title
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
Official Title
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2034 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
Detailed Description
Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE. The ACURATE IDE study cohorts include the following. Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]). There will be up to 1,500 subjects in the RCT. Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis. 4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device. ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts. ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve; Medtronic, Inc., Dublin, Ireland]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts. ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety. All subjects implanted will be followed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and then annually for up to 10 years post-procedure. Enrolled subjects who do not have a study device implanted will be assessed through 1-year post-procedure for safety/adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ACURATE Valve - Main Randomized
Arm Type
Experimental
Arm Description
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. *A subset of subjects will also be enrolled in the 4D CT Imaging Substudy.
Arm Title
ACURATE Valve - Single-arm Roll-in
Arm Type
Experimental
Arm Description
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
Arm Title
Commercial Valve - Main Randomized
Arm Type
Active Comparator
Arm Description
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. *A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy.
Arm Title
ACURATE Valve - Single-arm Prime XL
Arm Type
Experimental
Arm Description
Patients assigned to this group will be implanted with ACURATE Prime™ transfemoral TAVR System XL. *50 subjects will be enrolled in the Prime™ XL Nested Registry
Arm Title
ACURATE Valve - Extended Durability Randomized
Arm Type
Experimental
Arm Description
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL. Only low risk patients are enrolled in this group.
Arm Title
Commercial Valve - Extended Durability Randomized
Arm Type
Active Comparator
Arm Description
Medtronic CoreValve TAVR System OR, Edwards SAPIEN 3 TAVR System Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device. Only low risk patients are enrolled in this group.
Arm Title
ACURATE Valve - Continued Access Study
Arm Type
Experimental
Arm Description
Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System (S, M, L) or ACURATE Prime™ transfemoral TAVR System XL.
Intervention Type
Device
Intervention Name(s)
ACURATE neo2™ Transfemoral TAVR System
Intervention Description
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Intervention Type
Device
Intervention Name(s)
Medtronic CoreValve TAVR System
Intervention Description
Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
Intervention Type
Device
Intervention Name(s)
Edwards SAPIEN 3 TAVR System
Intervention Description
Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
Intervention Type
Device
Intervention Name(s)
ACURATE Prime™ Transfemoral TAVR System XL
Intervention Description
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Primary Outcome Measure Information:
Title
Composite rate of all-cause mortality, all stroke, and rehospitalization at 1 year in the Main Randomized Cohort.
Description
Primary Effectiveness Endpoint; A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death and stroke to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis.
Time Frame
Participants will be followed for the duration of hospital stay, through 1 year
Other Pre-specified Outcome Measures:
Title
Mortality: all-cause, cardiovascular, and non-cardiovascular
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Stroke: disabling and non-disabling
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Bleeding: life-threatening (or disabling) and major
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Title
Major vascular complications
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Title
Number of participants with a repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of Participants with hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with new permanent pacemaker implantation resulting from new or worsened conduction disturbances
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with new onset of atrial fibrillation or atrial flutter
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Acute kidney injury (AKI; ≤7 days post index procedure): based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 7 days post index procedure.
Title
Number of participants with Coronary obstruction: periprocedural
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed through 72 hours post index procedure
Title
Number of participants with Ventricular septal perforation
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed through 72 hours post index procedure
Title
Number of participants with Mitral apparatus damage: periprocedural
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed through 72 hours post index procedure
Title
Number of participants with Cardiac tamponade: periprocedural
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed through 72 hours post index procedure
Title
Number of participants with Valve migration
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Valve embolization
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Ectopic valve deployment
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Transcatheter aortic valve (TAV)-in-TAV deployment
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Prosthetic aortic valve thrombosis
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Prosthetic aortic valve endocarditis
Description
Safety endpoint adjudicated by an independent Clinical Events Committee (CEC)
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years.
Title
Number of participants with Successful vascular access, delivery and deployment of the study valve, and successful retrieval of the delivery system (site reported assessment)
Description
Device Performance endpoint, as measured by site reported data
Time Frame
Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Title
Grade of aortic valve regurgitation: paravalvular, central and combined (echocardiographic assessment)
Description
Device Performance endpoint, as assessed by Echocardiographic Core Laboratory
Time Frame
Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)
Title
Number of participants with Device Success
Description
Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area [iEOA] >0.85 cm2/m2 for BMI <30 kg/cm2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity < 3m/sec, and no moderate or severe prosthetic valve aortic regurgitation)
Time Frame
Participants will be followed for the duration of their procedure, an expected average of 1 day (post-procedure)
Title
Prosthetic aortic valve performance; Effective Orifice Area (EOA
Description
Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
Prosthetic aortic valve performance; Mean Aortic Gradient
Description
Mean aortic gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
Prosthetic aortic valve performance; Peak Aortic Gradient
Description
Peak Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
Prosthetic aortic valve performance; Peak Aortic Velocity
Description
Peak Aortic Velocity as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
Prosthetic aortic valve performance; Grade of Aortic Regurgitation
Description
Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
New York Heart Association (NYHA) Functional Status classification
Description
Evaluated by New York Heart Association (NYHA) classification
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4, 5, 7 and 10 years.
Title
Neurological status; National Institutes of Health Stroke Scale (NIHSS) Assessment
Description
- National Institutes of Health Stroke Scale (NIHSS) at discharge and 1 year
Time Frame
Participants will be followed at discharge and 1 year.
Title
Neurological status; Modified Rankin Scale (mRS) Assessment
Description
- Modified Rankin Scale (mRS) at discharge and all follow-up visits through 5 years
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1, 2, 3, 4 and 5 years.
Title
Neurological status; Neurological physical exam assessment
Description
- Neurological physical exam in all subjects where stroke is suspected
Time Frame
Participants will be followed for the duration of the trial, through 10 years.
Title
Health Status; Kansas City Cardiomyopathy Quality of Life questionnaire Assessment
Description
Evaluated by Kansas City Cardiomyopathy Quality of Life questionnaire
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.
Title
Health Status; SF-12 Quality of Life questionnaire Assessment
Description
Evaluated by SF-12 Quality of Life questionnaire
Time Frame
Participants will be followed for the duration of hospital stay, through 30 days, 1 and 5 years.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation. IC2. Subject has a documented aortic annulus size of ≥20.5 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device. IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II. IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate. IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent. IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits. IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy. Exclusion Criteria: EC1. Subject has a unicuspid or bicuspid aortic valve. EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation). EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment. EC4. Subject is on renal replacement therapy or has eGFR <20. EC5. Subject has a pre-existing prosthetic aortic or mitral valve. EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation. EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76). EC8. Subject has a need for emergency surgery for any reason. EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention. EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3. EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions. EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate [PET]). EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment. EC15. Subject has hypertrophic cardiomyopathy. EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed). EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization. EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%. EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices. EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use. EC21. Subject has either of the following: Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis. EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study. EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure. EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation. EC25. Subject has severe incapacitating dementia. Additional exclusion criteria apply to subjects considered for enrollment in the CT Imaging Substudy as listed below. AEC1. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V) AEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm. AEC3. Subject is expected to undergo chronic anticoagulation therapy after the index procedure. Note: Subjects treated with short-term anticoagulation post procedure can be included in the CT Imaging Substudy; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Currier
Phone
508-683-4927
Email
Lisa.Currier@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj R. Makkar, MD
Organizational Affiliation
Cedars-Sinai Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Reardon, MD
Organizational Affiliation
Methodist DeBakey Heart & Vascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, MD
Phone
205-975-1888
Email
mahmed@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Mustafa Ahmed, MD
Facility Name
Banner Good Samaritan
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marvin Eng, MD
Phone
313-916-2008
Email
meng1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Marvin Eng, MD
Facility Name
HonorHealth Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
TMC HealthCare
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Waggoner, MD
Phone
520-324-5512
Email
tom.waggoner@pimaheart.com
First Name & Middle Initial & Last Name & Degree
Thomas Waggoner, MD
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Ruiz-Rodriguez, MD
Phone
216-744-5430
Email
eruizrodz@gmail.com
First Name & Middle Initial & Last Name & Degree
Ernesto Ruiz-Rodriguez, MD
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Teirstein, MD
Phone
858-824-5222
Email
Teirstein.paul@scrippshealth.org
First Name & Middle Initial & Last Name & Degree
Paul Teirstein, MD
Facility Name
Kaiser Permanente Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somjot Brar, MD
Phone
323-783-3168
Email
somjot.s.brar@kp.org
First Name & Middle Initial & Last Name & Degree
Somjot Brar, MD
Facility Name
Cedars-Sinai Heart Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
Phone
310-423-3977
Email
raj.makkar@cshs.org
First Name & Middle Initial & Last Name & Degree
Raj R Makkar, MD
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Southard, MD
Phone
916-734-5639
Email
jasouthard@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Southard, MD
Facility Name
Kaiser Permanente - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Withdrawn
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lowell Satler, MD
Phone
202-877-5975
Email
lowell.f.satler@medstar.net
First Name & Middle Initial & Last Name & Degree
Lowell Satler, MD
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijaykumar Kasi, MD
Phone
407-841-6444
Email
Vijay.Kasi@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Vijaykumar Kasi, MD
Facility Name
Emory University Hospital (Midtown)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Withdrawn
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Rajagopal, MD
Phone
404-605-6517
Email
vivek.rajagopal@piedmont.org
First Name & Middle Initial & Last Name & Degree
Vivek Rajagopal, MD
Facility Name
NorthShore University Health Study Coordinator
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NorthShore University H Study Coordinator, MD
Phone
847-570-2250
Email
jlevisay@northshore.org
First Name & Middle Initial & Last Name & Degree
Justin Levisay, MD
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Ramana, MD
Phone
708-597-7656
Email
rramana@heartcc.com
First Name & Middle Initial & Last Name & Degree
Ravi Ramana, MD
Facility Name
St. John's Hospital (Prairie)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Vincent's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Horwitz, MD
Phone
319-356-3689
Email
phillip-horwitz@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Phillip Horwitz, MD
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Wang, MD
Phone
410-554-2332
Email
john.wang@medstar.net
First Name & Middle Initial & Last Name & Degree
John Wang, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Inglessis, MD
Phone
617-724-8052
Email
iinglessis@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ignacio Inglessis, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Sabe, MD
Phone
617-732-7678
Email
asabe@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ashraf Sabe, MD
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Phone
734-232-4276
Email
chetcuti@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Phone
612-863-4590
Email
paul.sorajja@allina.com
First Name & Middle Initial & Last Name & Degree
Paul Sorajja, MD
Facility Name
CentraCare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Stegman, MD
Phone
320-251-2700
Email
brian.stegman@centracare.com
First Name & Middle Initial & Last Name & Degree
Brian Stegman, MD
Facility Name
St. Joseph's Hospital-St. Paul
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marat Yanavitski, MD
Phone
651-326-4448
Email
marat.yanavitski@fairview.org
First Name & Middle Initial & Last Name & Degree
Marat Yanavitski, MD
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph DeGregorio, MD
Phone
973-743-1121
Email
joseph.degregorio@ehmchealth.org
First Name & Middle Initial & Last Name & Degree
Joseph DeGregorio, MD
Facility Name
Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Samy, MD
Phone
518-262-9777
Email
samys@amc.edu
First Name & Middle Initial & Last Name & Degree
Sanjay Samy, MD
Facility Name
Montefiore-Jack D. Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Azeem Latib, MD
Phone
917-471-1201
Email
mlatib@montefiore.org
First Name & Middle Initial & Last Name & Degree
Mohamed Azeem Latib, MD
Facility Name
Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Phone
716-829-2663
Email
viyer@kaleidahealth.org
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annapoorna Kini, MD
Phone
212-241-4021
Email
Annapoorna.Kini@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Annapoorna Kini, MD
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamim Nazif, MD
Phone
212-342-2101
Email
tmn31@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Tamim Nazif, MD
Facility Name
Cornell Presbyterian - New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shing-Chiu Wong, MD
Phone
212-746-4644
Email
scwong@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Shing-Chiu Wong, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Vavalle, MD
Phone
984-974-7921
Email
john_vavalle@med.unc.edu
First Name & Middle Initial & Last Name & Degree
John Vavalle, MD
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rinaldi, MD
Phone
704-355-2000
Email
michael.rinaldi@carolinashealthcare.org
First Name & Middle Initial & Last Name & Degree
Michael Rinaldi, MD
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Lindner Center for Research and Education at Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Choo, MD
Phone
513-585-1777
Email
joseph.choo@thechristhospital.com
First Name & Middle Initial & Last Name & Degree
Joseph Choo, MD
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme Attizzani, MD
Phone
216-844-7737
Email
Guilherme.attizzani@uhhospitals.org
First Name & Middle Initial & Last Name & Degree
Guilherme Attizzani, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, MD
Phone
216-444-6735
Email
kapadis@ccf.org
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, MD
Facility Name
Mount Carmel Columbus Cardiology Consultants
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Withdrawn
Facility Name
OhioHealth Research and Innovation Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, MD
Phone
614-566-5149
Email
steven.yakubov@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, MD
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Providence Heart Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Korngold, MD
Phone
503-216-0900
Email
ethan.korngold@providence.org
First Name & Middle Initial & Last Name & Degree
Ethan Korngold, MD
Facility Name
Sacred Heart Medical Center - Riverbend
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sudeshna Banerjee, MD
Phone
541-484-4332
Email
sbanerjee@peacehealth.org
First Name & Middle Initial & Last Name & Degree
Sudeshna Banerjee, MD
Facility Name
UPMC - Pinnacle
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UPMC Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Completed
Facility Name
Lankenau
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Gnall, MD
Phone
484-476-1000
Email
gnalle@mlhs.org
First Name & Middle Initial & Last Name & Degree
Eric Gnall, DO
Facility Name
WellSpan York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Harvey, MD
Phone
717-851-2441
Email
jharvey3@wellspan.org
First Name & Middle Initial & Last Name & Degree
James Harvey, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Steinberg, MD
Phone
843-876-4747
Email
steinbe@musc.edu
First Name & Middle Initial & Last Name & Degree
Daniel Steinberg, MD
Facility Name
Lexington Medical Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St Thomas Ascension
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Austin Heart
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Zidar, MD
Phone
512-421-3827
Email
frank.zidar@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Francis Zidar, MD
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Stoler, MD
Phone
214-820-9903
Email
robert.stoler@bswhealth.org
First Name & Middle Initial & Last Name & Degree
Robert Stoler, MD
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Park, MD
Phone
214-369-3613
Email
jamespark@texashealth.org
First Name & Middle Initial & Last Name & Degree
James Park, MD
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Kleiman, MD
Phone
713-441-1100
Email
NKleiman@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Neil Kleiman, MD
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhijeet Dhoble, MD
Phone
713-500-6550
Email
abhijeet.dhoble@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Abhijeet Dhoble, MD
Facility Name
Baylor Regional Medical Center at Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivasa Potluri, MD
Phone
469-800-6300
Email
srinivasa.potluri@bswhealth.org
First Name & Middle Initial & Last Name & Degree
Srinivasa Potluri, MD
Facility Name
Methodist Healthcare System of San Antonio dba Methodist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Alvarez, MD
Phone
210-393-6486
Email
jorge.alvarez@mhshealth.com
First Name & Middle Initial & Last Name & Degree
Jorge Alvarez, MD
Facility Name
The University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold Dauerman, MD
Phone
802-847-3734
Email
harold.dauerman@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Harold Dauerman, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Ragosta, MD
Phone
434-924-2420
Email
Mr8b@virginia.edu
First Name & Middle Initial & Last Name & Degree
Michael Ragosta, MD
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepak Talreja, MD
Phone
757-388-5480
Email
talreja@yahoo.com
First Name & Middle Initial & Last Name & Degree
Deepak Talreja, MD
Facility Name
Providence Regional Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Bellin Health
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Ricci, MD
Phone
920-433-3640
Email
jason.ricci@bellin.org
First Name & Middle Initial & Last Name & Degree
Jason Ricci, MD
Facility Name
Aurora Research Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanvir Bajwa, MD
Phone
414-649-6180
Email
tanvir.bajwa@aah.org
First Name & Middle Initial & Last Name & Degree
Tanvir Bajwa, MD
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panayotis Fasseas, MD
Phone
414-955-6778
Email
pfasseas@mcw.edu
First Name & Middle Initial & Last Name & Degree
Panayotis Fasseas, MD
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Chan, MD
Phone
(604) 520-3858
Email
albert.chan@fraserhealth.ca
First Name & Middle Initial & Last Name & Degree
Albert Chan, MD
Facility Name
Providence Health - St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Webb, MD
Phone
604-682-2344
Email
webb@providencehealth.bc.ca
First Name & Middle Initial & Last Name & Degree
John Webb, MD
Facility Name
London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier de l'Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Institut de Cardiologie de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

Learn more about this trial

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

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