Transcatheter JenaValve or J-Valve treatment for severe aortic regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Prince of Wales Hospital
  Hong Kong, Shatin, Hong Kong Recruiting

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.