NCT07021612 A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
| NCT ID | NCT07021612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong |
| Condition | Aortic Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-04-01 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Frequently Asked Questions
Who can join the NCT07021612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07021612 currently recruiting?
Yes, NCT07021612 is actively recruiting participants. Visit ClinicalTrials.gov or contact Prince of Wales Hospital, Shatin, Hong Kong to inquire about joining.
Where is the NCT07021612 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07021612 clinical trial?
NCT07021612 is sponsored by Prince of Wales Hospital, Shatin, Hong Kong. The trial plans to enroll 30 participants.