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

Trial Phase: Academic

Sponsor: JenaValve Technology, Inc.

Disqualifiers: Congenital valve, Prosthetic valve, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

180 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the JenaValve Trilogy System treatment for aortic regurgitation?

The JenaValve Trilogy System is designed to treat aortic regurgitation by using clips to attach directly to the heart's native valve leaflets, providing a secure fit. It has been approved in Europe for both aortic stenosis and regurgitation, and early clinical experiences suggest it offers a promising solution for patients who cannot undergo traditional surgery. ^{1 2 3 4 5}

Is the JenaValve Trilogy System safe for humans?

The JenaValve Trilogy System has been used in patients with aortic stenosis and aortic regurgitation, showing promising safety results in various studies. It has been approved in Europe and is under investigation in the United States, with reports of successful implantation and follow-up in patients. ^{1 2 3 4 5}

How is the JenaValve Trilogy System treatment different from other treatments for aortic regurgitation?

The JenaValve Trilogy System is unique because it uses a clipping mechanism to attach directly to the native valve leaflets, providing a secure anchor without relying on calcification, which is often absent in aortic regurgitation. This system is designed for transfemoral delivery, making it less invasive than traditional surgical options, and is specifically approved for both aortic stenosis and regurgitation in Europe. ^{1 2 3 4 6}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TAVR) using the JenaValve Trilogy Heart Valve System

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and effectiveness, focusing on primary outcomes such as stroke, major bleeding, and other complications

30 days

2 visits (in-person)

Extended Follow-up

Participants are monitored for long-term outcomes including all-cause mortality and KCCQ improvement

1 year

Periodic visits (in-person)

Treatment Details

Interventions

• JenaValve Pericardial TAVR System
• JenaValve Trilogy Heart Valve System

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+

Findings from Research

The JenaValve transcatheter heart valve (THV) demonstrated a high procedural success rate of 95% in a study of 180 high-risk patients with aortic stenosis, indicating its safety and effectiveness for transapical aortic valve replacement (TA-TAVR).

At one-year follow-up, the JenaValve showed a combined efficacy of 80.8% and no significant complications such as annular rupture or coronary ostia obstruction, suggesting it is a reliable option for patients with specific anatomical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. Silaschi, M., Treede, H., Rastan, AJ., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

A heart valve dedicated for aortic regurgitation: Review of technology and early clinical experience with the transfemoral Trilogy system. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

"First experience with JenaValve™: a single-centre cohort". [2021]

6. France pubmed.ncbi.nlm.nih.gov

First-in-human implantation of a novel transfemoral selfexpanding transcatheter heart valve to treat pure aortic regurgitation. [2018]