Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
- Conditions
- Aortic Valve Disease
- Interventions
- Other: no intervention
- Registration Number
- NCT05389631
- Lead Sponsor
- Helios Health Institute GmbH
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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.
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- TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
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- Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Epic VinV no intervention VinV TAVI procedure in patients who have previously received an Epic valve Trifecta VinV no intervention VinV TAVI procedure in patients who have previously received a Trifecta valve
- Primary Outcome Measures
Name Time Method composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction 30 days coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection.
- Secondary Outcome Measures
Name Time Method freedom from other major VARC2 complications up to 60 months patients with unplanned coronary obstruction 30-days coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection.
freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke up to 60 months freedom from each individual Major Adverse Cardiac Event endpoint up to 60 months all-cause mortality 30-days freedom from other major Valve Academic Research Consortium 2 (VARC2) complications day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate up to 60 months
Trial Locations
- Locations (5)
University Hospitals Leuven
🇧🇪Leuven, Belgium
Heart Center Dresden University Hospital
🇩🇪Dresden, Germany
University Hospital Jena
🇩🇪Jena, Germany
Heart Center Leipzig University Hospital
🇩🇪Leipzig, Germany
Catharina Hospital Eindhoven
🇳🇱Eindhoven, Netherlands