JenaValve Pericardial TAVR System for Aortic Regurgitation

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JenaValve Technology, Inc.

Disqualifiers: Congenital valve, Prosthetic valve, Endocarditis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 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 Pericardial TAVR System treatment for aortic regurgitation?

The JenaValve Pericardial TAVR System has shown promise in treating aortic regurgitation, as it uses a unique clipping mechanism to secure the valve, which has been effective in both transapical and transfemoral approaches. Initial studies and case reports indicate successful implantation and good outcomes, especially in patients who are not suitable for traditional surgery. ^{1 2 3 4 5}

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

The JenaValve Pericardial TAVR 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 makes it a promising option for patients who are at high risk for traditional surgery and have had limited success with other transcatheter valves. ^{1 2 3 4 6}

What is the purpose of this trial?

This trial examines using TAVR with the JenaValve to treat patients with severe Aortic Regurgitation. TAVR is a less invasive procedure that replaces the faulty heart valve through a small cut, helping blood flow correctly. The JenaValve is a new type of heart valve implanted through a specific method.

Research Team

Stephan Baldus, MD

Principal Investigator

Herzzentrum der Universität zu Köln

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 traditional open-heart valve replacement surgery. They should have symptoms that affect their daily activities (NYHA class II or higher). Participants must understand the study and agree to its terms with written consent. Those with abnormal aortic valve morphology, previous valve replacements, active infections, urgent heart conditions, or severe mitral regurgitation cannot join.

Inclusion Criteria

The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

I have symptoms when I do physical activity.

I have severe leakage in my aortic valve.

Exclusion Criteria

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

I need an urgent heart valve replacement.

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

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 Pericardial TAVR System

1 day

1 visit (in-person)

Immediate Post-Procedure Monitoring

Participants are monitored for peri-procedural myocardial infarction and other immediate complications

72 hours

Follow-up

Participants are monitored for safety and effectiveness, including mortality and stroke-free survival

1 year

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• JenaValve Pericardial TAVR System

Trial Overview The ALIGN-AR EFS TRIAL is evaluating the JenaValve Pericardial TAVR System as a treatment option for severe Aortic Regurgitation. This condition causes blood to leak back into the heart chamber due to an improperly closing valve. The trial aims to gather data on this less invasive alternative to open-heart surgery.

Participant Groups

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

TAVR with JenaValve Pericardial Valve and Delivery 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

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

2. 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]

3. 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]

4. 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]

5. France pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Implantation for Severe Pure Aortic Regurgitation With Dedicated Devices. [2022]