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

Prince of Wales Hospital, Shatin, Hong Kong30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Disease

Interventions

JenaValveDEVICE

JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Presence of leaflet thrombosis

Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography

Time frame: 6 month

Presence of leaflet thrombosis

Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography

Time frame: 6 month

Presence of leaflet thrombosis

Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography

Time frame: 6 month

Secondary Outcomes

Magnetic Resonance Imaging (MRI)

Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP

Time frame: 1 month

Magnetic Resonance Imaging (MRI)

Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP

Time frame: 1 month

Magnetic Resonance Imaging (MRI)

Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP

Time frame: 1 month

Magnetic Resonance Imaging (MRI)

Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP

Time frame: 1 month