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:

  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

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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Page 1 of 1 (1 locations)

1

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong, 0000

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