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The Navitor Japan Study is designed to evaluate the safety and performance of the Navitorâ„¢ valve used in combination with the FlexNavâ„¢ delivery system in a contemporary, real-world setting.
A prospective, single-arm, observational, multicenter post-market clinical study enrolling approximately 100 Japanese patients with symptomatic, severe aortic stenosis. The study will evaluate the safety and performance of the Navitor TAVI system, including future commercially available iterations, as they become available in Japan. Enrolled subjects will undergo follow-up at discharge, 30 days and 1-year post-index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | This study will enroll subjects of all genders from the population of patients qualifying for TAVI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navitor Transcatheter Aortic Valve Implantation | Device | Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor valve, the FlexNav Delivery system and the Navitor Loading System. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively | 30 days post index procedure |
| Primary Performance Endpoint | The primary performance endpoint is moderate or greater paravalvular leak (PVL) at 30 days as measured on a transthoracic echocardiogram (TTE) by the echocardiographic core laboratory. This endpoint will be reported as % subjects with moderate or greater PVL at 30 days. | 30 days post index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic, severe aortic stenosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bart Janssens | Contact | +32471723201 | bart.janssens@abbott.com | |
| Alicia Kimber | Contact | +1 415-917-9696 | alicia.kimber@abbott.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kokura Memorial Hospital | Recruiting | Fukuoka | Japan |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Shonan Kamakura General Hospital | Recruiting | Kanagawa | Japan |
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| Osaka Keisatsu Hospital | Recruiting | Osaka | Japan |
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