Status:
RECRUITING
A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
Lead Sponsor:
Prince of Wales Hospital, Shatin, Hong Kong
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 patien...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Chronic Kidney Disease with eGFR <30 ml/min/1.73m2.
- Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
- Contraindicated for CT or MRI assessment
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07021612
Start Date
April 1 2025
End Date
September 30 2028
Last Update
June 15 2025
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong, 0000