A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation

Launched by PRINCE OF WALES HOSPITAL, SHATIN, HONG KONG · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcatheter aortic valve implantation (TAVI) using special devices for patients with a condition known as severe aortic regurgitation (AR). AR is when the heart's aortic valve does not close properly, allowing blood to flow backwards into the heart. This trial aims to determine how effective this treatment is for patients who have severe symptoms that do not improve with regular medication and who are considered too high-risk for traditional heart surgery.

To participate in this trial, patients must be between the ages of 65 and 74, be experiencing significant symptoms of AR, and have been evaluated by a team of heart specialists who agree that TAVI is a suitable option. Participants will receive the TAVI procedure and will be monitored closely afterward to assess their recovery and the effectiveness of the treatment. It is important to note that certain health conditions, such as active infections or severe kidney disease, may prevent someone from joining the trial. Overall, this study could help improve treatment options for patients with aortic regurgitation in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
• • 2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
• • 3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
• • 4. Capable of providing informed consent
• Exclusion Criteria:
• • 1. Evidence of intracardiac mass, thrombus or vegetation
• • 2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
• • 3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
• • 4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
• • 5. Chronic Kidney Disease with eGFR \<30 ml/min/1.73m2.
• • 6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
• • 7. Contraindicated for CT or MRI assessment