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Clinical Trial Summary

Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers


Clinical Trial Description

Anonymized pre-, intra-, and postoperative data will be collected from patients undergoing VinV TAVI in a previously implanted Trifecta™ valve, Trifecta™ GT, Epic™ or Epic™ Supra valve from the largest volume implanters of the Trifecta and Epic valve in Europe until June 2020. The data will be analyzed in order to give a comprehensive description of clinical outcomes for Trifecta VinV procedures, to identify preoperative risk factors for coronary obstruction, 30-day and 1-year mortality, and other major complications, and to analyze the effects of patient characteristics and / or protective maneuvers in order to prevent coronary obstruction. Differences of Trifecta and Epic failed patients will also be analyzed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05389631
Study type Observational
Source Helios Health Institute GmbH
Contact Michael Borger, MD, PhD
Phone +49 341 865-1422
Email michael.borger@helios-gesundheit.de
Status Recruiting
Phase
Start date August 17, 2022
Completion date December 31, 2023

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