JenaValve Pericardial TAVR System for Aortic Regurgitation

Not currently recruiting at 20 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with severe aortic regurgitation, a condition where the heart's aortic valve fails to close properly, causing blood to leak back into the heart. The trial employs the JenaValve Pericardial TAVR System, a device designed to replace the faulty valve without open-heart surgery. It seeks participants with severe symptoms such as fatigue and shortness of breath who are at high risk for regular valve surgery. As an unphased trial, this study provides a unique opportunity to access innovative treatment options that could enhance quality of life.

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 prior data suggests that the JenaValve Pericardial TAVR System is safe for treating aortic regurgitation?

Research has shown that the JenaValve Pericardial TAVR System is generally safe for treating aortic regurgitation. One study reported high success rates for the device with manageable complication levels. Importantly, no deaths occurred during the procedure, and only 1.4% of patients died within 30 days afterward. Another study with 500 patients found that 26.2% experienced safety concerns within 30 days, which is considered low. Additionally, long-term results over five years indicate stable valve function and good patient health, suggesting this treatment is a promising option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The JenaValve Pericardial TAVR System is unique because it offers a minimally invasive way to treat aortic regurgitation, which is a condition where the heart's aortic valve doesn't close tightly, allowing blood to flow backward. Traditional treatments often involve open-heart surgery, which can be risky and require long recovery times. The JenaValve system is designed to be implanted via a catheter, meaning it can be placed without open-heart surgery, reducing recovery time and potentially lowering the risk for patients. Researchers are excited about this because it could make treatment accessible to patients who are not suitable candidates for surgery, offering a safer and quicker alternative.

What evidence suggests that the JenaValve Pericardial TAVR System is effective for aortic regurgitation?

Research has shown that the JenaValve Pericardial TAVR System, which participants in this trial will receive, is promising for treating severe aortic regurgitation (AR). Studies found it successful in over 95% of 500 patients, surpassing the 80-85% success rates of similar systems. Additionally, no deaths occurred during the procedure, and only 1.4% of patients passed away within 30 days. Long-term evidence indicates that the valve remains effective and stable for five years. This suggests that the JenaValve Pericardial TAVR System is a strong option for those needing treatment for severe AR. ^{2 3 4 5 6}

Who Is on the Research Team?

Vinod Thourani, MD

Principal Investigator

Piedmont Healthcare

Stephan Baldus, MD

Principal Investigator

Herzzentrum der Universität zu Köln

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/27/17/51/align-ar

TAVR With JenaValve for Symptomatic Aortic Regurgitation ... The study demonstrated high device success alongside acceptable complication rates, including a 0% procedural death rate, 1.4% 30-day mortality, 1.6% valve ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02732704

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR ... In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation. Official Title.

3. jacc.org jacc.org/doi/10.1016/j.jaccas.2024.102670

Long-Term Outcomes and Durability of a Novel Dedicated ... Long-term (5-year) outcomes demonstrate sustained valve hemodynamics and clinical stability, highlighting J-Valve as a promising minimally invasive alternative ...

4. jenavalve.com jenavalve.com/align-ar-first-500-patients-data/

ALIGN-AR First 500 Patients Data “We now have a device success rate of over 95% across 500 patients compared to the success rates of 80 to 85% with available TAVR valves when used in AR ...

5. jenavalve.com jenavalve.com/

JenaValve This session takes a look at the future of TAVR for aortic regurgitation, examining the imaging challenges of AR evaluation, how the JenaValve Trilogy System ...

6. jenavalve.com jenavalve.com/align-ar-2-year-follow-up-data-at-tct-2024/

ALIGN-AR 2-Year Follow-Up Data at TCT 2024 The 2-year data also reported excellent hemodynamic outcomes, very low rates of paravalvular leak, and sustained improvements in quality of life ...