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

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)

NCT03635424•Medtronic Cardiovascular

View on ClinicalTrials.gov

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

Eligibility

Age

60 - No limit years

Sex

ALL

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.
+26 more criteria

Locations (25)

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

Key Dates

Start Date

October 30, 2018

Primary Completion Date

November 13, 2019

Completion Date

December 1, 2030

Last Updated

October 21, 2025

Enrollment

150

ACTUAL participants

Conditions

Bicuspid Aortic Valve

Interventions

Medtronic TAVR Systems

DEVICE

Cardiovascular Health Improvement Project

NCT02306200

Aortic AneurysmAortic Dissection+3 more

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RECRUITING

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

NCT05739253

Aortic StenosisAscending Aortic Dilatation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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