Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Helios Health Institute GmbH

Status

Completed

Conditions

Aortic Valve Disease

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05389631

2019-0249 / SH 10702

Details and patient eligibility

About

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

Full 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.

Enrollment

76 patients

Sex

All

Volunteers

No Healthy Volunteers

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
1. Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV