Trifecta and Epic ViV Detailed Insights Into Management Strategies and Outcomes

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389631
• Other study ID #: 2019-0249 / SH 10702
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Disease

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