JenaValve Trilogy System for Aortic Regurgitation

(ALIGN-AR Trial)

Recruiting at 32 trial locations

Overseen By Vinny Podichetty, Vice President: Clinical & Med Affairs

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.

Research Team

Vinod Thourani, MD

Principal Investigator

Piedmont Healthcare

Torsten P. Vahl, MD

Principal Investigator

New York-Presbyterian/ Columbia University Medical Center

Martin B. Leon, MD

Principal Investigator

New York-Presbyterian/ Columbia University Medical Center

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 understand the study details and have signed the consent form.

I have severe leakage in my aortic valve.

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

Exclusion Criteria

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

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

You have had a prosthetic aortic valve (made of artificial materials) implanted in the past.

Treatment Details

Interventions

• JenaValve Pericardial TAVR System (Heart Valve Replacement)
• JenaValve Trilogy Heart Valve System (Heart Valve Replacement)

Trial Overview 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.

Participant Groups

Group I: Transcatheter Aortic Valve Replacement (TAVR) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

JenaValve Technology, Inc.

Lead Sponsor

Trials

8

Recruited

2,200+