JenaValve Trilogy System for Aortic Regurgitation (ALIGN-AR Trial)

Recruiting in Palo Alto (17 mi)

+32 other locations

Renowned Surgeon Vinod Thourani, M.D. ...

Overseen ByTorsten P. Vahl, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: JenaValve Technology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial examines using a new heart valve replacement procedure to treat patients with severe Aortic Regurgitation. The procedure replaces the faulty heart valve to improve blood flow and reduce symptoms like fatigue and shortness of breath. The new valve is designed to be self-expanding and has a specific mechanism for secure placement.

Eligibility Criteria

This trial is for patients with severe aortic regurgitation who are at high risk for open heart surgery and show symptoms like fatigue and shortness of breath. They must be informed about the study, agree to its terms, and have given written consent. People with previous aortic valve replacements, severe mitral regurgitation, certain congenital heart conditions, active infections or those in need of urgent heart procedures cannot participate.

Inclusion Criteria

I have severe leakage in my aortic valve.

I experience symptoms when doing regular activities due to my heart condition.

I am considered high risk for traditional heart valve surgery.

Exclusion Criteria

I have severe leakage in my heart's mitral valve.

I need medication or a device to help my heart pump blood.

I was born with a one or two-flap aortic valve.

I do not have an active infection or endocarditis.

I need an urgent heart valve replacement.

Participant Groups

The JenaValve ALIGN-AR Pivotal Trial is testing the JenaValve Trilogy Heart Valve System as a treatment option for symptomatic severe Aortic Regurgitation (AR). This condition causes blood to leak back into the heart chamber because the valve doesn't close tightly.

1Treatment groups

Experimental Treatment

Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention

TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System