Skip to main content
OpenTrials
Completed

NCT Number: NCT05389631

Trifecta and Epic ViV 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction

    Time frame: 30 days

    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.

Secondary outcomes

  1. all-cause mortality

    Time frame: 30-days

  2. patients with unplanned coronary obstruction

    Time frame: 30-days

    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.

  3. freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke

    Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier

  4. freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke

    Time frame: 1 year

  5. freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke

    Time frame: up to 60 months

  6. freedom from each individual Major Adverse Cardiac Event endpoint

    Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier

  7. freedom from each individual Major Adverse Cardiac Event endpoint

    Time frame: 1 year

  8. freedom from each individual Major Adverse Cardiac Event endpoint

    Time frame: up to 60 months

  9. freedom from other major Valve Academic Research Consortium 2 (VARC2) complications

    Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier

  10. freedom from other major VARC2 complications

    Time frame: 1 year

  11. freedom from other major VARC2 complications

    Time frame: up to 60 months

  12. post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate

    Time frame: day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier

  13. post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate

    Time frame: 1 year

  14. post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate

    Time frame: up to 60 months

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 25, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.