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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPrince of Wales Hospital, Shatin, Hong Kong

About this trial

Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery.

TAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.

Eligibility criteria

Qualifiers

receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH

with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy

Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)

Capable of providing informed consent

Disqualifiers

Evidence of intracardiac mass, thrombus or vegetation

Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT

Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure

Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.

Trial design

Treatments tested in this trial

  • JenaValve
  • J-Valve

Treatment groups

30 Participants
are divided into 1 treatment group