Trifecta™ Durability Study

The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. The Trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Trifecta™ aortic bioprosthesis

• Study Type: Observational
• Enrollment (Actual): 1151

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Universitat Herzzentrum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that are candidates for implantation or have been implanted over the past 9 months with a Trifecta™ aortic valve.

Description

Inclusion Criteria:

• Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a Trifecta™ valve, as per current guidelines
• Patient requires aortic valve replacement.
• Patient is legal age in host country.
• Patients must be able and willing to provide written informed consent to participate in this investigation
• Patients must be willing and able to comply with all follow-up requirements

Exclusion Criteria:

• Patients with contraindication for cardiac surgery
• Patients who are pregnant.
• Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
• Patient has active endocarditis
• Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
• Patient is undergoing renal dialysis.
• Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
• Patient has a documented thrombus in left atrium or left ventricle.
• Patient had in the past mitral or tricuspid valve replacement.
• Patient needs mitral and/or tricuspid valve replacement.
• Patient has an Ejection Fraction < 25%
• Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
• Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
• Patient has a life expectancy less than two years.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trifecta™ Valve Group; Subjects implanted with the Trifecta™ aortic bioprosthesis.	Device: Trifecta™ aortic bioprosthesis; Surgical aortic valve replacement with the Trifecta™ valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actuarial Freedom From Reintervention Due to Structural Valve Deterioration	Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actuarial Freedom From All-cause Mortality	Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.	10 years
Freedom From Valve Related Mortality	Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.	10 years
Freedom From Structural Valve Deterioration	Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.	10 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Sven Lehmann, Universitat Herzzentrum Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 7, 2010
• First Posted (Estimated): December 8, 2010

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CS-10-012-EU-TV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO