New hope for heart valve patients: less invasive procedure tested

NCT ID NCT03635424

Ongoing 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.

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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

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