JenaValve Trilogy System for Aortic Regurgitation

(ALIGN-AR Trial)

Not currently recruiting at 34 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve system for severe aortic regurgitation, a condition where the heart's aortic valve doesn't close properly, causing blood to leak back into the heart. The trial aims to determine if the JenaValve Trilogy Heart Valve System (also known as the JenaValve Pericardial TAVR System) can effectively help people with symptoms like fatigue and shortness of breath. Participants with severe aortic regurgitation who are at high risk for open-heart surgery are being sought. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to new treatment options.

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 Trilogy System is safe for treating aortic regurgitation?

Research has shown that the JenaValve Trilogy Heart Valve System is safe for treating severe aortic regurgitation, a condition where the heart valve doesn't close properly. One study reported no deaths during the procedure, and only 1.4% of patients passed away within 30 days, indicating that most patients handle the treatment well. Long-term results have demonstrated that the valve continues to work effectively, helping patients remain stable. Another study confirmed the device's safety and effectiveness even after two years. These findings suggest that the JenaValve Trilogy is a promising option for people with severe aortic regurgitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The JenaValve Trilogy Heart Valve System is unique because it offers a novel approach to treating aortic regurgitation through transcatheter aortic valve replacement (TAVR). Unlike traditional surgical valve replacement, which requires open-heart surgery, the JenaValve system allows for a less invasive procedure, potentially reducing recovery time and risks associated with major surgery. Additionally, the JenaValve system is specifically designed to address aortic regurgitation, providing a tailored fit and improved sealing to prevent blood leakage, which is a common issue with current valves. Researchers are excited about this treatment because it promises to expand treatment options for patients who are high-risk or inoperable with conventional surgical methods.

What evidence suggests that the JenaValve Trilogy Heart Valve System is effective for aortic regurgitation?

Research has shown that the JenaValve Trilogy Heart Valve System, which participants in this trial will receive, effectively treats aortic regurgitation, a condition where the heart valve doesn't close properly. Studies have found the device to be highly successful, with no deaths during the procedure and low death rates within 30 days after. Patients have experienced significant improvements in heart function and quality of life. Long-term results, up to five years, indicate that the valve continues to perform well, offering a stable and less invasive option for those with severe aortic regurgitation. Overall, the JenaValve system provides promising results for patients needing heart valve replacement. ^{1 3 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 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 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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. 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 ...

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. 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.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2474870624001015

Quantitative Aortography Analysis of JenaValve's Trilogy ... Quantitative aortography confirms the low rates of AR and the large reduction in RF following the implantation of Jenavalve's Trilogy THV, irrespective of ...

6. jenavalve.com jenavalve.com/trilogy-system/

Trilogy System The Trilogy Valve with locator technology finally gives high-risk patients with severe, symptomatic aortic regurgitation a TAVI treatment option.