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This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV). Additional analyses or calculations may be obtained from the imaging or evaluations already performed per the sites' standard of care
The study is an open-label observational study involving a minimum of 10 centers. A minimum of 100 patients, including a minimum of 30 stand-alone balloon aortic valvuloplasty (BAV) treatment patients, will be enrolled. Enrollment will continue until all 3 of these conditions are met.
BAV-only patients will be followed through a 6-month post-treatment telephone follow up. Patients treated with the V8 device for BAV as a bridge to transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) or as an intraprocedural predilatation prior to TAVR, will exit the study at the time of the TAVR or SAVR implant or at 6 months post-BAV treatment, whichever comes first.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V8 Balloon Aortic Valvuloplasty (BAV) Catheter | Device | The V8 device can be used for BAV as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: V8 Device Performance | Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation. | Intra-procedure |
| Safety Endpoint: Serious Adverse Events (SAE) | The composite of SAEs as defined by the Valve Academic Research Consortium (VARC). | Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint: Intra-Procedure Hemodynamic Changes | Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA). | Intra-procedure |
| Efficacy Endpoint: Post-Procedure Hemodynamic Changes |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic - Patients at each enrolling clinic who are to be treated with the InterValve V8 device for balloon aortic valvuloplasty (BAV) are eligible for enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritin Hospital | Los Angeles | California | 90017 | United States | ||
| University of Southern Califormia |
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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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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
| Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.) |
| Safety Endpoint: Aortic Valve (AV) Block at Discharge | At discharge, which is expected to be within 72 hours procedure. |
| Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up | 6-Month Follow-up |
| Los Angeles |
| California |
| 90033 |
| United States |
| Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation) | Minneapolis | Minnesota | 55407 | United States |
| Centennial Heart | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8802 | United States |
| Henrico's Doctors' Hospital | Richmond | Virginia | 23229 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| D014694 |
| Ventricular Outflow Obstruction |