Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Patient implanted with J-Valve or JenaValve TAVI system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JenaValve | Device | JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of leaflet thrombosis | Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography | 6 month |
| Presence of leaflet thrombosis | Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography | 6 month |
| Presence of leaflet thrombosis | Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP | 1 month |
| Magnetic Resonance Imaging (MRI) | Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Shatin | 0000 | Hong Kong |
Not provided
Not provided
Not provided
Not provided
| J-Valve | Device | J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech. |
|
| 1 month |
| Magnetic Resonance Imaging (MRI) | Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP | 1 month |
| Magnetic Resonance Imaging (MRI) | Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP | 1 month |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline | Baseline |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at post-OP | Up to 1-month post-OP |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at 1 year post-OP | 1-year |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at baseline | Baseline |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at post-OP | Up to 1-month post-OP |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at 1 year post-OP | 1-year |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at baseline | Baseline |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at post-OP | Upto 1-month post-OP |
| Computed Tomographic Endpoints | Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at 1 year post-OP | 1-year |
| Computed Tomographic Endpoints | To obtain the native valve dimensions using CT imaging at pre-OP (baseline) | Baseline |
| Computed Tomographic Endpoints | To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at post-OP | Up to 1-month post-OP |
| Computed Tomographic Endpoints | To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 6 month post-OP | 6-month |
| Computed Tomographic Endpoints | To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 12 month post-OP | 1-year |
| Computed Tomographic Endpoints | To obtain the impanted Transcatheter valve location using CT imaging at post-OP | Up to 1-month post-OP |
| Computed Tomographic Endpoints | To compare the impanted Transcatheter valve location using CT imaging with post-OP at 6 month post-OP | 6-month |
| Computed Tomographic Endpoints | To compare the impanted Transcatheter valve location using CT imaging with post-OP at 12 month post-OP | 1-year |
| Computed Tomographic Endpoints | To obtain the native valve leaflet overhang using CT imaging at pre-OP (baseline) | Baseline |
| Computed Tomographic Endpoints | To obtain the impanted valve leaflet overhang using CT imaging at post-OP | Up to 1-month post-OP |
| Computed Tomographic Endpoints | To compare the impanted valve leaflet overhang using CT imaging with post-OP at 6 month post-OP | 6-month |
| Computed Tomographic Endpoints | To compare the impanted valve leaflet overhang using CT imaging with post-OP at 12 month post-OP | 1-year |
| Echocardiographic Endpoints | To grade AR Severity using echocardiography at baseline ii. Mean Aortic valve pressure gradient iii. Left Ventricular Ejection Fraction (LVEF) iv. Paravalvular leak severity | Baseline |
| Echocardiographic Endpoints | To grade AR Severity using echocardiography at Day 1-7 post-OP | day 1-7 |
| Echocardiographic Endpoints | To grade AR Severity using echocardiography at Day30 post-OP | day 30 |
| Echocardiographic Endpoints | To grade AR Severity using echocardiography at 6 months post-OP | 6-month |
| Echocardiographic Endpoints | To grade AR Severity using echocardiography at 1 year post-OP | 1-year |
| Echocardiographic Endpoints | To obtain Mean Aortic valve pressure gradient using echocardiography at baseline | Baseline |
| Echocardiographic Endpoints | To obtain Mean Aortic valve pressure gradient using echocardiography at Day 1-7 post OP | day 1-7 |
| Echocardiographic Endpoints | To obtain Mean Aortic valve pressure gradient using echocardiography at Day 30 post OP | day 30 |
| Echocardiographic Endpoints | To obtain Mean Aortic valve pressure gradient using echocardiography at 6 months post OP | 6-month |
| Echocardiographic Endpoints | To obtain Mean Aortic valve pressure gradient using echocardiography at 12 months post OP | 1-year |
| Echocardiographic Endpoints | To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at baseline | Baseline |
| Echocardiographic Endpoints | To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 1-7 post OP | Day 1-7 post OP |
| Echocardiographic Endpoints | To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 30 post OP | Day30 post OP |
| Echocardiographic Endpoints | To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 6 months post OP | 6 months post OP |
| Echocardiographic Endpoints | To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 12 months post OP | 12 months post OP |
| Echocardiographic Endpoints | To evaluate Paravalvular leak severity using echocardiography at Day 1-7 post OP | Day 1-7 post OP |
| Echocardiographic Endpoints | To evaluate Paravalvular leak severity using echocardiography at Day 30 post OP | Day 30 post OP |
| Echocardiographic Endpoints | To evaluate Paravalvular leak severity using echocardiography at 6 months post OP | 6 months post OP |
| Echocardiographic Endpoints | To evaluate Paravalvular leak severity using echocardiography at 12 months post OP | 12 months post OP |
| cardiovascular Mortality events | cardiovascular Mortality event up till 12 months post-OP | 12 months post OP |
| Myocardial Infarction event | Myocardial Infarction (MI) event up till 12 months post-OP | 12 months post OP |
| Stroke event | Stroke event up till 12 months post-OP | 12 months post OP |
| New onset renal failure event | New onset renal failure requiring unplanned dialysis or renal replacement therapyevent up till 12 months post-OP | 12 months post OP |
| Severe Bleeding event | Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC) event up till 12 months post-OP | 12 months post OP |
| Non-elective aortic valve surgery event | Non-elective aortic valve surgery event up till 12 months post-OP | 12 months post OP |
| Non-elective transcatheter re-intervention event | Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP | 12 months post OP |
| Major cardiac structural complications | Major cardiac structural complications event up till 12 months post-OP | 12 months post OP |
| Major access site complications | Major access site complications event up till 12 months post-OP | 12 months post OP |
| New pacemaker implantation event | New pacemaker implantation due to AV block event up till 12 months post-OP | 12 months post OP |
| Acute Device Success Rate | 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 | immediately post-OP |
| Procedural Success Rate | 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. | immediately post-OP |
| All-cause mortality | 30-day all-cause mortality rate of subjects | 30-day |
| All-cause mortality | 1-year all-cause mortality rate of subjects | 1-year |
| heart failure hospitalization | 30-day heart failure hospitalization rate of subjects | 30-day |
| heart failure hospitalization | 1 year heart failure hospitalization rate of subjects | 1-year |
| NYHA Functional Class | NYHA Functional Class of subjects at baseline | Baseline |
| NYHA Functional Class | NYHA Functional Class of subjects at post-OP | Post-OP |
| NYHA Functional Class | NYHA Functional Class of subjects at 1 month post-OP | 1 month Post-OP |
| NYHA Functional Class | NYHA Functional Class of subjects at 6-month post-OP | 6-month Post-OP |
| NYHA Functional Class | NYHA Functional Class of subjects at 12-month post-OP | 12-month Post-OP |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided