CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
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|ClinicalTrials.gov Identifier: NCT02209298|
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis||Device: CoreValve Transcatheter Valve|
|Study Type :||Observational|
|Actual Enrollment :||202 participants|
|Official Title:||Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 3, 2018|
CoreValve Transcatheter Valve
Medtronic CoreValve SystemTM is designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve. The support frame is manufactured by Nitinol, which has multi-level, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from a single layer of porcine pericardium into a tri-leaflet configuration. The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound derived from oleic acid, a naturally occurring long-chain fatty acid. AOA™ is an antimineralization treatment shown to reduce both early and late valvular calcification.
Device: CoreValve Transcatheter Valve
Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.
- Cardiovascular death [ Time Frame: 30 days post-index procedure ]
- Lack of significant aortic stenosis or insufficiency [ Time Frame: 1 year Follow-up ]
- Safety composite endpoint based on VARC-II endpoint definitions [ Time Frame: At 30 days and during follow-up visits ]
- Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient [ Time Frame: At 30 days and during follow-up visits ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209298
|Principal Investigator:||Didier Tchetche, Dr.||Clinique Pasteur Toulouse|
|Principal Investigator:||Jean-Philippe Verhoye, Prof.||Centre Hospitalier Universitaire, Rennes|
|Principal Investigator:||Ran Kornowski, Prof.||Rabin Medical Center, Tel Aviv|