Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device (TAB-R)
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||6 Months|
|Official Title:||Transluminal Aortic Balloon Valvuloplasty Registry (TAB-R)|
- Efficacy Endpoint: V8 Device Performance [ Time Frame: Intra-procedure ]Successful balloon fixation: proximal and distal balloon segments are securely fixed on either side of the aortic valve annulus following inflation.
- Safety Endpoint: Serious Adverse Events (SAE) [ Time Frame: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.) ]The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).
- Efficacy Endpoint: Intra-Procedure Hemodynamic Changes [ Time Frame: Intra-procedure ]Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
- Efficacy Endpoint: Post-Procedure Hemodynamic Changes [ Time Frame: Within 72 hours of procedure or discharge, whichever is first. (Typical discharge is expected to be within 72 hours.) ]Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
- Safety Endpoint: Aortic Valve (AV) Block at Discharge [ Time Frame: At discharge, which is expected to be within 72 hours procedure. ]
- Safety Endpoint: Aortic Valve (AV) Block at 6-Month Follow-up [ Time Frame: 6-Month Follow-up ]
|Study Start Date:||March 2014|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Device: V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- as stand-alone intervention
- as a bridge to transcatheter aortic valve replacement (TAVR)
- as a bridge to surgical aortic valve replacement (SAVR)
- as an intraprocedural predilatation prior to TAVR
The V8 device can be used for BAV as follows:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02099942
|United States, California|
|Good Samaritin Hospital|
|Los Angeles, California, United States, 90017|
|University of Southern Califormia|
|Los Angeles, California, United States, 90033|
|United States, Minnesota|
|Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation)|
|Minneapolis, Minnesota, United States, 55407|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-8802|
|United States, Virginia|
|Henrico's Doctors' Hospital|
|Richmond, Virginia, United States, 23229|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|