Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trifecta VinV<br>VinV TAVI procedure in patients who have previously received a Trifecta valve | Other: no intervention<br>* no intervention<br>|
| Epic VinV<br>VinV TAVI procedure in patients who have previously received an Epic valve | Other: no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 30-days | 
| patients with unplanned coronary obstruction | 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. | 30-days | 
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke |  | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | 
| freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke |  | 1 year | 
| 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 |  | day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier | 
| freedom from each individual Major Adverse Cardiac Event endpoint |  | 1 year | 
| freedom from each individual Major Adverse Cardiac Event endpoint |  | up to 60 months | 
| 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 | 
| freedom from other major VARC2 complications |  | 1 year | 
| freedom from other major VARC2 complications |  | up to 60 months | 
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate |  | 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 |  | 1 year | 
| post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate |  | up to 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VinV TAVI, Trifecta valve, Epic valve