JenaValve Heart Valve System for Aortic Valve Disease

(JENA-VAD Trial)

Recruiting at 14 trial locations

Overseen By Lisa Boyle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: JenaValve Technology, Inc.

Must not be taking: Antibiotics, Antiplatelets

Disqualifiers: Coronary artery disease, Kidney disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the JenaValve Trilogy Heart Valve System for individuals with specific heart conditions. It targets those with a continuous flow left ventricular assist device (a pump that helps the heart) and significant aortic regurgitation (a condition where the heart valve doesn't close properly). The trial aims to determine if this new system can safely and effectively replace the faulty valve. Ideal participants are those experiencing significant heart issues due to their current valve and pump setup. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance heart valve treatments for future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known allergy or contraindication to aspirin, heparin, ticlopidine, clopidogrel, or certain metals, you may not be eligible to participate.

What prior data suggests that the JenaValve Trilogy Heart Valve System is safe for TAVR in LVAD patients?

Research has shown that the JenaValve Trilogy Heart Valve System is generally safe for people with aortic valve problems. In a study of the first 500 patients, the valve succeeded in over 95% of cases, outperforming other valves used for similar issues. Importantly, no deaths occurred during the procedure, and only a small number of patients (1.4%) passed away within 30 days after receiving the valve.

Another study tracked patients for two years and found that the valve continued to work well and safely over time. This indicates that the valve not only works effectively at first but remains reliable. Overall, these findings suggest that the JenaValve Trilogy Heart Valve System is well-tolerated and has a strong safety record for those who need it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The JenaValve Trilogy Heart Valve System is unique because it offers a less invasive approach to treating aortic regurgitation in patients with continuous flow left ventricular assist devices (cfLVAD). Unlike traditional surgical valve replacement, which requires open-heart surgery, this system uses a transcatheter aortic valve replacement (TAVR) technique, allowing for the valve to be delivered through a catheter. This method is particularly exciting as it reduces recovery time and lowers the risk associated with major surgery, making it a promising option for patients who are not ideal candidates for conventional surgery. Researchers are thrilled about its potential to improve outcomes and quality of life for these patients.

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

Research has shown that the JenaValve Trilogy™ Heart Valve System succeeds in over 95% of patients needing a transcatheter aortic valve replacement (TAVR). This trial will specifically evaluate TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR). Studies have found that this valve facilitates smooth blood flow through the heart. Leakage around the valve occurs at very low rates, and patients experience lasting improvements in their quality of life. Long-term data indicates that the valve functions well and remains stable for at least five years. Additionally, no deaths have occurred during the procedure, and complications shortly afterward are rare. ^{1 2 3 4 6}

Who Is on the Research Team?

Vinod Thourani, MD

Principal Investigator

Piedmont Heart Institute

Nir Uriel, MD

Principal Investigator

Columbia University

Gabriel Sayer, MD

Principal Investigator

Columbia University

Ravi Ramana, DO

Principal Investigator

advocate christ medical center

Are You a Good Fit for This Trial?

This trial is for individuals with severe aortic regurgitation or valve disease, who are already using devices to help their heart pump blood and have symptoms like fatigue or shortness of breath (NYHA class III/IV). They must be at high risk for traditional open-heart valve surgery and have the right anatomy for the JenaValve Trilogy Heart Valve System. Participants need to consent to follow-up visits.

Inclusion Criteria

Patient with high risk for surgical aortic valve replacement (SAVR) as documented by Heart Team

Patient or the patient's legal representative has provided written informed consent

My heart's structure can support the JenaValve Trilogy™ Heart Valve System.

Exclusion Criteria

I have a thickened heart muscle, with or without blockage.

I have not had a stroke or mini-stroke in the last 6 months.

Previous prosthetic aortic valve (bioprosthesis or mechanical) implant

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

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after TAVR procedure

1 year

Multiple visits over 1 year

What Are the Treatments Tested in This Trial?

Interventions

• JenaValve Trilogy Heart Valve System

Trial Overview The safety and effectiveness of the JenaValve Trilogy Heart Valve System are being tested in patients with left ventricular assist devices (LVADs) suffering from significant aortic regurgitation. The study aims to see if this system can replace traditional surgical methods.

How Is the Trial Designed?

Group I: TAVR in LVAD Patients Experimental Treatment 1 Intervention

Transcatheter Aortic Valve Replacement (TAVR) TAVR in patients with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR)

Who Is Running the Clinical Trial?

JenaValve Technology, Inc.

Lead Sponsor

Trials

8

Recruited

2,200+

Citations

1. 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 ...

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. 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39290676/

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

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04415047

NCT04415047 | The JenaValve ALIGN-AR Pivotal Trial In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.