Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation

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

This project will try two transcatheter heart valves (JenaValve and J-Valve) to treat people with severe symptomatic aortic regurgitation who are high risk for open-heart surgery.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong, Shatin)
• Trial ID: NCT07021612 on ClinicalTrials.gov

What this trial studies

This is an observational clinical and imaging registry of patients with severe symptomatic pure aortic regurgitation who undergo transcatheter aortic valve implantation with the JenaValve or J-Valve. Eligible patients are those judged high risk for surgical valve replacement by a multidisciplinary heart team and who can provide informed consent. Participants will have clinical follow-up and serial imaging (echocardiography and CT) to document device anchoring, valve function, left ventricular remodeling, and any subclinical leaflet thrombosis. Data are collected at a single center to build real-world evidence on performance and durability of these dedicated devices for aortic regurgitation.

Who should consider this trial

Good fit: Ideal candidates are adults with severe symptomatic pure aortic regurgitation (NYHA III-IV) deemed high risk for surgical valve replacement who are planned to receive JenaValve or J-Valve and can give informed consent.

Not a fit: Patients unlikely to benefit include those with intracardiac thrombus or vegetation, active infection or recent sepsis, unsuitable aortic anatomy for device deployment, severe kidney failure (eGFR <30 ml/min/1.73m2), cardiogenic shock, or participation in another conflicting investigational device trial.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive option that reduces symptoms and surgical risk for patients with severe aortic regurgitation.

How similar studies have performed: Small case series and registries of dedicated transcatheter valves for aortic regurgitation have shown procedural feasibility and symptomatic improvement, but large randomized trials and long-term durability data are still limited.

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

Where this trial is running

Hong Kong, Shatin

• Prince of Wales Hospital — Hong Kong, Shatin, Hong Kong (Recruiting)

Conditions Aortic Valve Disease; Transcatherter Aortic Valve Intervention