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Medtronic CoreValve Evolut R U.S. Clinical Study

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoreValve Evolut R TAVR system
Sponsored by
Medtronic Cardiovascular
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 - Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.

Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of >40 mmHg or a maximal aortic valve velocity of >4.0 m/sec, AND aortic valve area of <1.0cm2 (or aortic valve area index of <0.6 cm2/m2).

  • STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities.
  • Symptoms of aortic stenosis, AND NYHA Functional Class II or greater
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria

  • Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media
  • Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
  • End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
  • Ongoing sepsis, including active endocarditis.
  • Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure.
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  • Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  • Subject refuses a blood transfusion.
  • Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  • Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
  • Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.
  • Currently participating in an investigational drug or another device study (excluding registries).
  • Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.
  • Need for emergency surgery for any reason.
  • Liver failure (Child-Pugh class C).
  • Subject is pregnant or breast feeding.

Anatomical exclusion criteria:

  • Pre-existing prosthetic heart valve in any position.
  • Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).
  • Severe mitral regurgitation.
  • Severe tricuspid regurgitation.
  • Moderate or severe mitral stenosis.
  • Hypertrophic obstructive cardiomyopathy.
  • Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation.
  • Congenital bicuspid or unicuspid valve verified by echocardiography.

For transfemoral or transaxillary (subclavian) acess:

- Access vessel diameter <5.0mm or <6.0mm for patent LIMA

Sites / Locations

  • Banner Good Samaritan Medical Center
  • University of Southern California
  • Yale New Haven Hospital
  • Washington Hospital Center/Medstar
  • St. Vincent Heart Center of Indiana/The Care Group, LLC
  • University of Kansas
  • The Johns Hopkins University
  • Beth Israel Deaconcess Medical Center
  • University of Michigan Health Systems
  • Detroit Medical Center Cardiovascular Institute
  • Spectrum Health
  • Morristown Memorial Hospital
  • New York Langone Medical Center
  • The Mount Sinai Medical Center
  • Columbia University Medical Center
  • St. Francis Hospital
  • Duke University Medical Center
  • Riverside Methodist Hospital/Ohio Health Research Institute
  • University of Pittsburg Medical Center
  • Pinnacle Health
  • Baylor Heart and Vascular Hospital
  • The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp
  • Aurora Health Care/St Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CoreValve Evolut R TAVR system

Arm Description

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)

Outcomes

Primary Outcome Measures

All-cause Mortality at 30 Days by Percent
Percentage of patients that died by any cause at 30 days
Percentage of Patients With Disabling Stroke at 30 Days
Stroke Diagnostic Criteria: > Acute episode of focal or global neurological deficit with at least 2 of the following: change in level of consciousness > hemiplegia, hemiparesis numbness or sensory loss affecting 1 side > dysphasia or aphasia hemianopia amaurosis fugax > other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: Neurological specialist > Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: > An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline
Percent Device Success Rate Between 24 and 7 Day
Percentage of patients with Device Success defined as: Absence of procedural mortality, AND Correct positioning of a single Evolut R valve into the proper anatomical location, AND Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND Absence of moderate or severe prosthetic valve regurgitation
Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.

Secondary Outcome Measures

Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)
Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
Coronary Artery Obstruction Requiring Intervention.
Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.
Percent VARC II Combined Safety Endpoint at 30 Days
VARC II composite safety endpoint rate includes percent freedom from the following components: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury: stage 2 or 3 (including renal replacement therapy). Coronary artery obstruction requiring intervention. Major vascular complication. Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).
Stage 2 Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR > Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 > 1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR Urine output <0.3 ml/kg/h for ≥24 h OR > Anuria for ≥12 h
Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate
Fatal bleeding (BARC type 5) OR > Bleeding in a critical organs, such as intracranial, intraspinal, > intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR > Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR > Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)
Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days
Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
Percent Resheath and Recapture Success Rate
Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.
Hemodynamic Performance -Mean Gradient
Mean gradient by Doppler echocardiography.
Major Vascular Complication
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR > Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR > Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR > The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR > Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR > Surgery for access site nerve injury OR > Permanent access related nerve injury
Hemodynamic Performance - Aortic Valve Area
Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.

Full Information

First Posted
July 24, 2014
Last Updated
October 31, 2022
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT02207569
Brief Title
Medtronic CoreValve Evolut R U.S. Clinical Study
Official Title
Medtronic CoreValve Evolut R United States IDE Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
Detailed Description
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation. The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoreValve Evolut R TAVR system
Arm Type
Experimental
Arm Description
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)
Intervention Type
Device
Intervention Name(s)
CoreValve Evolut R TAVR system
Primary Outcome Measure Information:
Title
All-cause Mortality at 30 Days by Percent
Description
Percentage of patients that died by any cause at 30 days
Time Frame
Assessed at 30 days post-implantation
Title
Percentage of Patients With Disabling Stroke at 30 Days
Description
Stroke Diagnostic Criteria: > Acute episode of focal or global neurological deficit with at least 2 of the following: change in level of consciousness > hemiplegia, hemiparesis numbness or sensory loss affecting 1 side > dysphasia or aphasia hemianopia amaurosis fugax > other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: Neurological specialist > Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: > An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline
Time Frame
Assessed at 30 days post-implantation
Title
Percent Device Success Rate Between 24 and 7 Day
Description
Percentage of patients with Device Success defined as: Absence of procedural mortality, AND Correct positioning of a single Evolut R valve into the proper anatomical location, AND Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND Absence of moderate or severe prosthetic valve regurgitation
Time Frame
Assessed at 24 hours to seven days post implantation
Title
Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
Description
Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.
Time Frame
Assessed at 24 hours to 7 days post implantation
Secondary Outcome Measure Information:
Title
Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)
Description
Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
Time Frame
Assessed at 30 days post-implantation
Title
Coronary Artery Obstruction Requiring Intervention.
Description
Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.
Time Frame
Assessed at 30 days post-implantation
Title
Percent VARC II Combined Safety Endpoint at 30 Days
Description
VARC II composite safety endpoint rate includes percent freedom from the following components: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury: stage 2 or 3 (including renal replacement therapy). Coronary artery obstruction requiring intervention. Major vascular complication. Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Time Frame
Assessed at 30 days post-implantation
Title
Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).
Description
Stage 2 Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR > Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 > 1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR Urine output <0.3 ml/kg/h for ≥24 h OR > Anuria for ≥12 h
Time Frame
Assessed at 30 days post-implantation
Title
Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate
Description
Fatal bleeding (BARC type 5) OR > Bleeding in a critical organs, such as intracranial, intraspinal, > intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR > Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR > Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)
Time Frame
Assessed at 30 days post-implantation
Title
Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days
Description
Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
Time Frame
Assessed at 30 days
Title
Percent Resheath and Recapture Success Rate
Description
Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.
Time Frame
Assessed intra-procedurally
Title
Hemodynamic Performance -Mean Gradient
Description
Mean gradient by Doppler echocardiography.
Time Frame
Assessed at baseline, 30 days, 6 months, and 1 year
Title
Major Vascular Complication
Description
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR > Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR > Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR > The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR > Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR > Surgery for access site nerve injury OR > Permanent access related nerve injury
Time Frame
Assessed at 30 days post-implantation
Title
Hemodynamic Performance - Aortic Valve Area
Description
Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
Time Frame
Assessed at baseline, 30 days, 6 months, and 1 year
Title
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
Description
Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.
Time Frame
Assessed at 30 days, 6 months, and 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria - Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram. Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of >40 mmHg or a maximal aortic valve velocity of >4.0 m/sec, AND aortic valve area of <1.0cm2 (or aortic valve area index of <0.6 cm2/m2). STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to frailty or co-morbidities. Symptoms of aortic stenosis, AND NYHA Functional Class II or greater The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Exclusion Criteria Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve). A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine and clopidogrel, Nitinol (titanium or nickel), contrast media Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. Untreated clinically significant coronary artery disease requiring revascularization. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min. Ongoing sepsis, including active endocarditis. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to the study procedure. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). Gastrointestinal (GI) bleeding that would preclude anticoagulation. Subject refuses a blood transfusion. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams. Currently participating in an investigational drug or another device study (excluding registries). Evidence of an acute myocardial infarction ≤ 30 days before the study procedure. Need for emergency surgery for any reason. Liver failure (Child-Pugh class C). Subject is pregnant or breast feeding. Anatomical exclusion criteria: Pre-existing prosthetic heart valve in any position. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation). Severe mitral regurgitation. Severe tricuspid regurgitation. Moderate or severe mitral stenosis. Hypertrophic obstructive cardiomyopathy. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation. Congenital bicuspid or unicuspid valve verified by echocardiography. For transfemoral or transaxillary (subclavian) acess: - Access vessel diameter <5.0mm or <6.0mm for patent LIMA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew R Williams, MD
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Washington Hospital Center/Medstar
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
St. Vincent Heart Center of Indiana/The Care Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconcess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Detroit Medical Center Cardiovascular Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
New York Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Riverside Methodist Hospital/Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pinnacle Health
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Aurora Health Care/St Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28183466
Citation
Popma JJ, Reardon MJ, Khabbaz K, Harrison JK, Hughes GC, Kodali S, George I, Deeb GM, Chetcuti S, Kipperman R, Brown J, Qiao H, Slater J, Williams MR. Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study. JACC Cardiovasc Interv. 2017 Feb 13;10(3):268-275. doi: 10.1016/j.jcin.2016.08.050.
Results Reference
derived

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Medtronic CoreValve Evolut R U.S. Clinical Study

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