JenaValve Heart Valve System for Aortic Valve Disease

(JENA-VAD Trial)

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

Trial Summary

What is the purpose of this trial?

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

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 data supports the effectiveness of the JenaValve Trilogy Heart Valve System treatment?

The JenaValve Trilogy Heart Valve System has shown promise in treating aortic regurgitation (a condition where the heart's aortic valve doesn't close tightly), especially for patients who cannot undergo traditional surgery. It uses clips to attach to the heart's native valve, providing a secure fit, and has been approved in Europe for both aortic stenosis (narrowing of the aortic valve) and regurgitation, indicating its effectiveness in these conditions. ^{1 2 3 4 5}

What makes the JenaValve Trilogy Heart Valve System unique for treating aortic valve disease?

The JenaValve Trilogy Heart Valve System is unique because it uses clips to attach directly to the native valve leaflets, allowing for anatomically correct implantation without the need for rapid pacing. It is designed for both aortic stenosis and regurgitation, and can be delivered through a less invasive transfemoral approach, making it suitable for patients who are at high risk for traditional surgery. ^{1 2 3 5 6}

Research Team

Vinod Thourani, MD

Principal Investigator

Piedmont Heart Institute

Ravi Ramana, M.D.

Principal Investigator

advocate christ medical center

Nir Uriel, MD

Principal Investigator

Columbia University

Gabriel Sayer, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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. 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]

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

Transapical transcatheter aortic valve implantation using the JenaValve™ system: acute and 30-day results of the multicentre CE-mark study. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. 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]

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

JenaValve. [2012]