Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 4:11 PM
Study NCT ID:
NCT02472106
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure
Sponsor:
InterValve, Inc.
Organization:
Study Overview
Official Title:
Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following Medtronic CoreValve or Other Self-Expanding TAVI Procedure (PostCorE)
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PostCorE
Brief Summary:
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: