Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device

CompletedOBSERVATIONAL
Enrollment

103

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

V8 Balloon Aortic Valvuloplasty (BAV) Catheter

"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"

Trial Locations (7)

23229

Henrico's Doctors' Hospital, Richmond

37203

Centennial Heart, Nashville

55407

Abbott Northwestern Hospital (with Minneapolis Heart Institute Foundation), Minneapolis

90017

Good Samaritin Hospital, Los Angeles

90033

University of Southern Califormia, Los Angeles

98195

University of Washington, Seattle

37232-8802

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

InterValve, Inc.

INDUSTRY

NCT02099942 - Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device | Biotech Hunter | Biotech Hunter