Aortic Valve Stenosis Clinical Trial
Official title:
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)
This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.
The study is a prospective, multi-center, single arm open-label clinical study involving up
to 5 centers and a minimum of 20 subjects. Up to 50 subjects may be enrolled in this study.
The first 3 post-dilatation procedures for each investigator will be considered roll-ins and
not included in the main study analyses. Subjects will exit the study at hospital discharge
or 7 days post treatment, whichever comes first. The expected duration of the clinical
investigation is approximately 6 months.
Subjects implanted with the CoreValve or other commercially available self-expanding TAVI
and with the use of the V8 as a postdilatation balloon may be enrolled in this study. The
subject will exit the study after the predischarge ECHO where the Paravalvular Leak (PVL)
measurements are taken or resolution of a V8 related AE (if applicable).
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Observational Model: Case-Only, Time Perspective: Prospective
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