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

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

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
• Germany
  • Dresden, Germany, 01307
    • Heart Center Dresden University Hospital
  • Jena, Germany, 07747
    • University Hospital Jena
  • Leipzig, Germany, 04289
    • Heart Center Leipzig University Hospital
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Catharina Hospital Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing VinV TAVI procedures who have previously received a Trifecta or Epic valve in large volume implantation centers until June 2020.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trifecta VinV; VinV TAVI procedure in patients who have previously received a Trifecta valve	Other: no intervention; no intervention
Epic VinV; VinV TAVI procedure in patients who have previously received an Epic valve	Other: no intervention; no intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helios Health Institute GmbH
• Collaborators: Abbott
• Investigators: Study Chair: Michael Borger, MD, PhD, Leipzig Heart Center

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: VinV TAVI; Trifecta valve; Epic valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: 2019-0249 / SH 10702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No