Status:
COMPLETED
Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
Lead Sponsor:
Helios Health Institute GmbH
Collaborating Sponsors:
Abbott
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
Brief 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 ao...
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 larges...
Eligibility Criteria
Inclusion
- Patients who underwent a TAVI VinV procedure post-Trifecta or Epic implantation
- Patients who underwent planned or unplanned concomitant percutaneous coronary intervention (PCI) during the index hospital admission will be included, as will those undergoing emergent conventional cardiac surgery.
Exclusion
- 1\. TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
- 2\. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Key Trial Info
Start Date :
August 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05389631
Start Date
August 17 2022
End Date
December 21 2023
Last Update
October 9 2024
Active Locations (5)
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1
University Hospitals Leuven
Leuven, Belgium, 3000
2
Heart Center Dresden University Hospital
Dresden, Germany, 01307
3
University Hospital Jena
Jena, Germany, 07747
4
Heart Center Leipzig University Hospital
Leipzig, Germany, 04289