NCT05389631

Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Helios Health Institute GmbH · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
OTHER	no intervention	no intervention

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2022-05-25
• Last updated: 2024-10-09

Locations

5 sites across 3 countries: Belgium, Germany, Netherlands