Actively Recruiting
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
Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2025-06-15
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of two advanced transcatheter aortic valve implantation (TAVI) devices, JenaValve and J-Valve, for patients with pure aortic regurgitation (AR). AR patients, who often face high risks with open heart surgery, have different heart flow and structure compared to those with aortic stenosis. The study focuses on understanding the unique challenges and follow-up needs, including the potential for leaflet thrombosis, in patients treated with these dedicated TAVI devices. Participants in this observational study receive TAVI treatment using either the JenaValve or J-Valve systems. These devices have special anchoring mechanisms designed for pure AR cases. The study involves detailed imaging assessments, including magnetic resonance imaging (MRI) and computed tomography (CT), performed at baseline, within one month after the procedure, and during follow-up periods at six months and one year. Echocardiographic evaluations and clinical event tracking are also conducted immediately after, and up to 12 months post-procedure. Throughout the study, participants undergo extensive monitoring with various imaging tests to detect leaflet thrombosis and assess heart function over time. Researchers will review cardiovascular events like stroke, heart attacks, and hospitalizations for heart failure. Patient symptoms and functional status will be evaluated at multiple time points up to one year. The study provides careful observation of device performance and patient outcomes over a prolonged period, lasting until September 2028.
CONDITIONS
Brief 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) using JenaValve or J-Valve at Prince of Wales Hospital
- Having severe symptomatic aortic regurgitation classified as NYHA class III-IV despite optimal medical therapy
- Considered high risk for aortic valve surgery by a multidisciplinary heart team
- Able to provide informed consent
You will not qualify if you...
- Presence of intracardiac mass, thrombus, or infection (vegetation)
- Anatomical issues preventing proper device placement or vascular access as shown by echo or CT
- Recent sepsis or active endocarditis within 3 months, or infections needing antibiotics within 2 weeks before planned procedure
- Currently enrolled in another clinical trial of an investigational drug or device not yet completed
- Chronic kidney disease with severe impairment (eGFR less than 30 ml/min/1.73m2)
- Cardiogenic shock or unstable heart conditions requiring inotropic drugs or ventricular assist devices
- Cannot undergo CT or MRI assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo transcatheter aortic valve implantation using the JenaValve or J-Valve system.
1 visit (in-person) for implantation procedure
Duration - Up to 12 months post-implantation
Participants are monitored with imaging and clinical assessments to evaluate valve function and safety.
Visits at baseline, day 1-7, 1 month, 6 months, and 12 months post-procedure
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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