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.
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
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.
Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
Cohort
Prospective
JenaValve
DeviceJenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
J-Valve
DeviceJ-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.
Presence of leaflet thrombosis
Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography
Presence of leaflet thrombosis
Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography
Presence of leaflet thrombosis
Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography
Magnetic Resonance Imaging (MRI)
Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP
Magnetic Resonance Imaging (MRI)
Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP
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