New hope for heart valve patients: less invasive procedure tested

NCT ID NCT03635424

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a less invasive procedure called TAVR to replace the aortic valve in 150 people who have a bicuspid aortic valve (a valve with two flaps instead of three) and severe narrowing. The goal is to see if it is safe and works well for people who are at low risk for open-heart surgery. Researchers will check for death, disabling stroke, and whether the new valve is placed correctly without major leakage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Medtronic Evolut PRO and Evolut R valve systems (a device placed via a catheter to replace the aortic valve)
What this could lead to: If successful, this could offer a less invasive treatment option for people with bicuspid aortic valve stenosis who are at low risk for open-heart surgery.
What could go wrong: This is a relatively small, early-stage study (150 people) focused on safety and device success. It may not prove long-term benefits or work for all patients. Risks include stroke, need for a pacemaker, or valve leakage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic valve disease 1 aortic valve disease 2 aortic valve stenosis Bicuspid Aortic Valve Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bicuspid aortic valve

Contacts and locations

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Baylor Jack and Jane Hamilton Heart & Vascular Hospital

Dallas, Texas, 75226, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
HealthPark Medical Center

Fort Myers, Florida, 33908, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States
Morton Plant Hospital

Clearwater, Florida, 33756, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Oregon Health & Science University Hospital

Portland, Oregon, 97239, United States
Paramount Heart

Villanova, Pennsylvania, 19085, United States
Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States
Saint Francis Hospital

Roslyn, New York, 11576, United States
Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States
Spectrum Health Hospital

Grand Rapids, Michigan, 49503, United States
Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States
The Mount Sinai Hospital

New York, New York, 10029, United States
UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101, United States
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of Michigan Health System

Ann Arbor, Michigan, 48109, United States
Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.