Actively Recruiting
A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2025-06-15
30
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving transcatheter aortic valve implantation (TAVI) with JenaValve or J-Valve
- Have severe symptomatic aortic regurgitation (NYHA class III-IV) despite optimal medical therapy
- Considered high risk for aortic valve surgery by a heart team
- Able to provide informed consent
You will not qualify if you...
- Presence of intracardiac mass, thrombus, or vegetation
- Anatomical issues preventing proper device placement or vascular access
- Sepsis or active endocarditis within 3 months, or infections needing antibiotics within 2 weeks before the procedure
- Currently in another investigational drug or device clinical trial that has not completed its primary endpoint
- Chronic kidney disease with eGFR less than 30 ml/min/1.73m2
- Cardiogenic shock or unstable condition needing inotropic support or ventricular assist device
- Contraindications for CT or MRI assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong, 0000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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