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Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Primary Purpose

Bicuspid Aortic Valve

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic TAVR Systems
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bicuspid Aortic Valve

Eligibility Criteria

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

Inclusion Criteria:

  1. Severe aortic stenosis, defined as follows:

    1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

    2. For asymptomatic patients:

    Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR

    Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR

    Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.

  2. Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
  3. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT.
  4. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
  2. Age less than 60 years
  3. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

    1. aspirin or heparin (HIT/HITTS) and bivalirudin
    2. ticlopidine and clopidogrel
    3. Nitinol (titanium or nickel)
    4. contrast media
  4. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  5. Ongoing sepsis, including active endocarditis.
  6. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
  7. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  10. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  11. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  12. Subject refuses a blood transfusion.
  13. 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).
  14. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  15. 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-up exams.
  16. Currently participating in an investigational drug or another device study (excluding registries).
  17. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria).
  18. Need for emergency surgery for any reason.
  19. Subject is pregnant or breast feeding.
  20. Subject is legally incompetent, or otherwise vulnerable

    Anatomical exclusion criteria:

  21. Pre-existing prosthetic heart valve in any position.
  22. Severe mitral regurgitation amenable to surgical replacement or repair.
  23. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  24. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  25. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  26. Prohibitive left ventricular outflow tract calcification.
  27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis
  28. Aortic annulus diameter of <18 or >30 mm.
  29. Significant ascending aortopathy requiring surgical repair
  30. Ascending aorta diameter > 4.5 cm

    For transfemoral or transaxillary (subclavian) access:

  31. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.

Sites / Locations

  • Abrazo Arizona Heart Hospital
  • Scripps Memorial Hospital La Jolla
  • Los Robles Hospital & Medical Center
  • Yale New Haven Hospital
  • Morton Plant Hospital
  • HealthPark Medical Center
  • Tallahassee Memorial Hospital
  • Piedmont Atlanta Hospital
  • Mercy Medical Center - Des Moines
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health System
  • Spectrum Health Hospital
  • Abbott Northwestern Hospital
  • North Shore University Hospital
  • The Mount Sinai Hospital
  • Saint Francis Hospital
  • University Hospitals Cleveland Medical Center
  • OhioHealth Riverside Methodist Hospital
  • Oregon Health & Science University Hospital
  • UPMC Pinnacle Harrisburg Campus
  • Baylor Jack and Jane Hamilton Heart & Vascular Hospital
  • Houston Methodist Hospital
  • Paramount Heart
  • Aurora St. Luke's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medtronic TAVR Systems

Arm Description

Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

Outcomes

Primary Outcome Measures

Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Rate of of all-cause mortality or disabling stroke rate at 30 days
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
Device success rate, defined as: Absence of procedural mortality, AND Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Secondary Outcome Measures

All-Cause Mortality Rate
Rate of all cause mortality
All Stroke (Disabling and Non-Disabling) Rate
Rate of disabling and non-disabling strokes
Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.
Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.
The rate of myocardial infarction at 30 days
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.
Rate of life-threatening (or disabling) bleeding at 30 days
Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.
Rate of prosthetic valve endocarditis at 30 days
Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.
Rate of prosthetic valve thrombosis at 30 days
Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.
Rate of valve-related dysfunction requiring repeat procedure at 30 days
Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.
Rate of repeat hospitalization for aortic valve disease at 30 days
Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.
Rate of repeat hospitalization for ascending aorta disease at 30 days
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days.
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days
Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days
Reporting of NYHA classification change from baseline to 30 days NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures: • KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.
QoL summary scores and change from baseline using the following measures: • EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state

Full Information

First Posted
July 31, 2018
Last Updated
October 19, 2023
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT03635424
Brief Title
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
Official Title
Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
Detailed Description
Multi-center, prospective, single arm All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medtronic TAVR Systems
Arm Type
Experimental
Arm Description
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
Intervention Type
Device
Intervention Name(s)
Medtronic TAVR Systems
Intervention Description
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
Primary Outcome Measure Information:
Title
Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Description
Rate of of all-cause mortality or disabling stroke rate at 30 days
Time Frame
30 days
Title
Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
Description
Device success rate, defined as: Absence of procedural mortality, AND Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
All-Cause Mortality Rate
Description
Rate of all cause mortality
Time Frame
1 year and annually through 10 years
Title
All Stroke (Disabling and Non-Disabling) Rate
Description
Rate of disabling and non-disabling strokes
Time Frame
1 year and annually through 10 years
Title
Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.
Description
Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)
Time Frame
30 days
Title
Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.
Description
The rate of myocardial infarction at 30 days
Time Frame
30 days
Title
Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.
Description
Rate of life-threatening (or disabling) bleeding at 30 days
Time Frame
30 days
Title
Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.
Description
Rate of prosthetic valve endocarditis at 30 days
Time Frame
30 days
Title
Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.
Description
Rate of prosthetic valve thrombosis at 30 days
Time Frame
30 days
Title
Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.
Description
Rate of valve-related dysfunction requiring repeat procedure at 30 days
Time Frame
30 days
Title
Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.
Description
Rate of repeat hospitalization for aortic valve disease at 30 days
Time Frame
30 days
Title
Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.
Description
Rate of repeat hospitalization for ascending aorta disease at 30 days
Time Frame
30 days
Title
Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days
Description
Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time Frame
30 days
Title
Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days.
Description
Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Time Frame
30 days
Title
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days
Description
Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure
Time Frame
30 days
Title
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days
Description
Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure
Time Frame
30 days
Title
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days
Description
Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure
Time Frame
30 days
Title
New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days
Description
Reporting of NYHA classification change from baseline to 30 days NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time Frame
30 days
Title
Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
Description
QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures: • KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame
30 days
Title
Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.
Description
QoL summary scores and change from baseline using the following measures: • EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe aortic stenosis, defined as follows: For symptomatic patients: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest For asymptomatic patients: Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%. Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT. 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 (eg, subject is indicated for mechanical prosthetic valve). Age less than 60 years A known hypersensitivity or contraindication to any of the following that 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. Ongoing sepsis, including active endocarditis. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery. 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 2 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 24 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-up 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 due to unstable coronary artery disease (WHO criteria). Need for emergency surgery for any reason. Subject is pregnant or breast feeding. Subject is legally incompetent, or otherwise vulnerable Anatomical exclusion criteria: Pre-existing prosthetic heart valve in any position. Severe mitral regurgitation amenable to surgical replacement or repair. Severe tricuspid regurgitation amenable to surgical replacement or repair. Moderate or severe mitral stenosis amenable to surgical replacement or repair. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. Prohibitive left ventricular outflow tract calcification. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis Aortic annulus diameter of <18 or >30 mm. Significant ascending aortopathy requiring surgical repair Ascending aorta diameter > 4.5 cm For transfemoral or transaxillary (subclavian) access: Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Reardon, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Forrest, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Basel Ramlawi, MD
Organizational Affiliation
Paramount Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abrazo Arizona Heart Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Scripps Memorial Hospital La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Los Robles Hospital & Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
HealthPark Medical Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
OhioHealth Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oregon Health & Science University Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Pinnacle Harrisburg Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Baylor Jack and Jane Hamilton Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Paramount Heart
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33031491
Citation
Forrest JK, Ramlawi B, Deeb GM, Zahr F, Song HK, Kleiman NS, Chetcuti SJ, Michelena HI, Mangi AA, Skiles JA, Huang J, Popma JJ, Reardon MJ. Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):50-57. doi: 10.1001/jamacardio.2020.4738.
Results Reference
derived

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Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

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