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

NCT ID: NCT03635424

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2030-12-31

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

Conditions

Bicuspid Aortic Valve

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medtronic TAVR Systems

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

Group Type: EXPERIMENTAL

Medtronic TAVR Systems

Intervention Type: DEVICE

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

Interventions

Medtronic TAVR Systems

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

Eligibility Criteria

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

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Reardon, MD

Role: STUDY_CHAIR

The Methodist Hospital Research Institute

John Forrest, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Basel Ramlawi, MD

Role: PRINCIPAL_INVESTIGATOR

Paramount Heart

Locations

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Morton Plant Hospital

Clearwater, Florida, United States

HealthPark Medical Center

Fort Myers, Florida, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Spectrum Health Hospital

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

North Shore University Hospital

Manhasset, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Saint Francis Hospital

Roslyn, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

Paramount Heart

Villanova, Pennsylvania, United States

Baylor Jack and Jane Hamilton Heart & Vascular Hospital

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33031491 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

10790330DOC

Identifier Type: -

Identifier Source: org_study_id