An observational study in Aortic Valve Stenosis, sponsored by InterValve, Inc.. Completed at 7 sites in United States. Per ClinicalTrials.gov, last updated 2016-03-01.
Sponsored by InterValve, Inc. · Observational
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 103 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →InterValve, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The V8 device can be used for BAV as follows: * 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
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.
Time frame: Intra-procedure
Safety Endpoint: Serious Adverse Events (SAE)
The composite of SAEs as defined by the Valve Academic Research Consortium (VARC).
Time frame: Intra-procedure until discharge or 72 hours post-procedure, whichever comes first. (Typical discharge is expected to be within 72 hours.)
Efficacy Endpoint: Intra-Procedure Hemodynamic Changes
Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Time frame: Intra-procedure
Efficacy Endpoint: Post-Procedure Hemodynamic Changes
Absolute and percent change in mean aortic valve (AV) gradient and aortic valve area (AVA).
Time frame: 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
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
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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InterValve, Inc.