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

Prince of Wales Hospital

Status: Enrolling

Conditions: Aortic Valve Disease

Treatments: Device: J-Valve; Device: JenaValve

Study type: Observational

Funder types: Other

Identifiers

NCT07021612

2025.079

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Interventional group

Description:

Patient implanted with J-Valve or JenaValve TAVI system

Treatment:

Device: JenaValve

Device: J-Valve