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This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alwide Plus | Paitents perfomed TAVR and have Alwlide Plus Balloon Catheter pre-dilaton or post-dilation |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with TAVI device success at immediate post-procedure | TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient <20mmHg, or peak velocity <3 m/s, and no severe aortic regurgitation or paravalvular leakage). | Immediate post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with balloon pre-dilation success | defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter | Immediate post-procedure |
| Percentage of paitents with balloon post-dilation success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering severe aortic stenosis and requiring pre-dilation during TAVR
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | China | |||
| Jiangxi Provincial People's Hospital |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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defined as successful access, delivery and dilation the transcatheter aortic valve, and retrieval for the AlwideTM Plus balloon catheter |
| Immediate post-procedure |
| Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKINā„2), major vascular complications and new permanent pacemaker implantation | Definition following VARC-2 criteria | Immediate post-procedure and 30 days post-procedure |
| Prosthetic valve performance-mean transvalular pressure gradient | Prosthetic valve performance-mean pressure gradient(assessed by echocardiography), unit -mmHg | Immediate post-procedure and discharge(within 7 days post-procedure) |
| Prosthetic valve performance-orifice area | Prosthetic valve performance-orifice area(assessed by echocardiography), unit -cm2 | Immediate post-procedure and discharge(within 7 days post-procedure) |
| Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage) | Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage), none/trace/mild/moderate/severe | Immediate post-procedure and discharge(within 7 days post-procedure) |
| Nanchang |
| Jiangxi |
| China |
| Yan'an Hospital of Kunming City | Kunming | Yunnan | China |
| Guangdong Provincial People's Hospital | Guangzhou | China |
| D014694 |
| Ventricular Outflow Obstruction |