Clinical trial NCT05389631: Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes
Official title: The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: VinV TAVI
Trifecta valve
Epic valve
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2022-05-25
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction
timeFrame: 30 days
Secondary outcomes:
measure: all-cause mortality
timeFrame: 30-days
measure: patients with unplanned coronary obstruction
timeFrame: 30-days
measure: freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
timeFrame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
measure: freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
timeFrame: 1 year
measure: freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke
timeFrame: up to 60 months
measure: freedom from each individual Major Adverse Cardiac Event endpoint
timeFrame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
measure: freedom from each individual Major Adverse Cardiac Event endpoint
timeFrame: 1 year
measure: freedom from each individual Major Adverse Cardiac Event endpoint
timeFrame: up to 60 months
measure: freedom from other major Valve Academic Research Consortium 2 (VARC2) complications
timeFrame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
measure: freedom from other major VARC2 complications
timeFrame: 1 year
measure: freedom from other major VARC2 complications
timeFrame: up to 60 months
measure: post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
timeFrame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
measure: post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
timeFrame: 1 year
measure: post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Dresden
country: Germany
facility: Heart Center Dresden University Hospital
city: Jena
country: Germany
facility: University Hospital Jena
city: Leipzig
country: Germany
facility: Heart Center Leipzig University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
Study officials:
affiliation: Leipzig Heart Center
name: Michael Borger, MD, PhD
role: STUDY_CHAIR
References: