Aortic Valve Disease
Conditions
Keywords
Transcatherter Aortic Valve Intervention
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 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
DEVICEJenaValve
JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
DEVICEJ-Valve
J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of leaflet thrombosis | 6 month | Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | 1 month | Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP |
| Computed Tomographic Endpoints | Baseline | Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline |
| Echocardiographic Endpoints | Baseline | To grade AR Severity using echocardiography at baseline ii. Mean Aortic valve pressure gradient iii. Left Ventricular Ejection Fraction (LVEF) iv. Paravalvular leak severity |
| cardiovascular Mortality events | 12 months post OP | cardiovascular Mortality event up till 12 months post-OP |
| Myocardial Infarction event | 12 months post OP | Myocardial Infarction (MI) event up till 12 months post-OP |
| Stroke event | 12 months post OP | Stroke event up till 12 months post-OP |
| New onset renal failure event | 12 months post OP | New onset renal failure requiring unplanned dialysis or renal replacement therapyevent up till 12 months post-OP |
| Severe Bleeding event | 12 months post OP | Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC) event up till 12 months post-OP |
| Non-elective aortic valve surgery event | 12 months post OP | Non-elective aortic valve surgery event up till 12 months post-OP |
| Non-elective transcatheter re-intervention event | 12 months post OP | Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP |
| Major cardiac structural complications | 12 months post OP | Major cardiac structural complications event up till 12 months post-OP |
| Major access site complications | 12 months post OP | Major access site complications event up till 12 months post-OP |
| New pacemaker implantation event | 12 months post OP | New pacemaker implantation due to AV block event up till 12 months post-OP |
| Acute Device Success Rate | immediately post-OP | Rate of successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure immediately post-OP |
| Procedural Success Rate | immediately post-OP | Rate of Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE. Subjects who die or undergo aortic valve surgery before discharge are procedure failures. |
| All-cause mortality | 30-day | 30-day all-cause mortality rate of subjects |
| heart failure hospitalization | 30-day | 30-day heart failure hospitalization rate of subjects |
| NYHA Functional Class | Baseline | NYHA Functional Class of subjects at baseline |
Countries
Hong Kong
Outcome results
None listed