Trifecta™ Durability Study

Terminated

Conditions: Aortic Valve Disease

Interventions: Device: Trifecta™ aortic bioprosthesis

Registration Number: NCT01256710

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1151

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trifecta™ Valve Group	Trifecta™ aortic bioprosthesis	Subjects implanted with the Trifecta™ aortic bioprosthesis.

Primary Outcome Measures

Name	Time	Method
Actuarial Freedom From Reintervention Due to Structural Valve Deterioration	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Actuarial Freedom From All-cause Mortality	10 years	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.
Freedom From Structural Valve Deterioration	10 years	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.
Freedom From Valve Related Mortality	10 years	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.