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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05389631
Other study ID # 2019-0249 / SH 10702
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 17, 2022
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Helios Health Institute GmbH
Contact Michael Borger, MD, PhD
Phone +49 341 865-1422
Email michael.borger@helios-gesundheit.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven
France Rennes University Hospital Rennes
Germany Heart Center Dresden University Hospital Dresden
Germany University Hospital Jena Jena
Germany Heart Center Leipzig University Hospital Leipzig
Netherlands Catharina Hospital Eindhoven Eindhoven

Sponsors (2)

Lead Sponsor Collaborator
Helios Health Institute GmbH Abbott

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 all-cause mortality 30-days
Secondary 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
Secondary 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
Secondary freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke 1 year
Secondary freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke up to 60 months
Secondary freedom from each individual Major Adverse Cardiac Event endpoint day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier
Secondary freedom from each individual Major Adverse Cardiac Event endpoint 1 year
Secondary freedom from each individual Major Adverse Cardiac Event endpoint up to 60 months
Secondary 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
Secondary freedom from other major VARC2 complications 1 year
Secondary freedom from other major VARC2 complications up to 60 months
Secondary 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
Secondary post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate 1 year
Secondary post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate up to 60 months
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