Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-17

Study Completion Date

2023-12-21

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

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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.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Trifecta VinV

VinV TAVI procedure in patients who have previously received a Trifecta valve

no intervention

Intervention Type OTHER

no intervention

Epic VinV

VinV TAVI procedure in patients who have previously received an Epic valve

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No