Menu
Recruiting NCT07021612

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

— Observational Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JenaValve, J-Valve.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device JenaValve
    JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
  • Device J-Valve
    J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.

Primary outcome measures

  • Presence of leaflet thrombosis [Time frame: 6 month]
  • Presence of leaflet thrombosis [Time frame: 6 month]
  • Presence of leaflet thrombosis [Time frame: 6 month]
Secondary outcome measures (12)
  • Magnetic Resonance Imaging (MRI) [Time frame: 1 month]
  • Magnetic Resonance Imaging (MRI) [Time frame: 1 month]
  • Magnetic Resonance Imaging (MRI) [Time frame: 1 month]
  • Magnetic Resonance Imaging (MRI) [Time frame: 1 month]
  • Computed Tomographic Endpoints [Time frame: Baseline]
  • Computed Tomographic Endpoints [Time frame: Up to 1-month post-OP]
  • Computed Tomographic Endpoints [Time frame: 1-year]
  • Computed Tomographic Endpoints [Time frame: Baseline]
  • Computed Tomographic Endpoints [Time frame: Up to 1-month post-OP]
  • Computed Tomographic Endpoints [Time frame: 1-year]
  • Computed Tomographic Endpoints [Time frame: Baseline]
  • Computed Tomographic Endpoints [Time frame: Upto 1-month post-OP]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT07021612 · 2025.079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗