Trifecta™ Durability Study

Abbott

Status

Terminated

Conditions

Aortic Valve Disease

Treatments

Device: Trifecta™ aortic bioprosthesis

Study type

Observational

Funder types

Industry

Identifiers

NCT01256710

CS-10-012-EU-TV

Details and patient eligibility

About

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.

Enrollment

1,151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.