This trial is active, not recruiting.

Condition aortic valve disorder
Treatment implantation of the trifecta valve
Sponsor St. Jude Medical
Start date January 2011
End date June 2021
Trial size 801 participants
Trial identifier NCT01256710, CS-10-012-EU-TV


The purpose of the SJM International, Inc. sponsored "Trifecta™ Durability Study", is to evaluate the long-term durability of the Trifecta™ valve.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
implantation of the trifecta valve
Implantation of the bioprothesis valve, Trifecta Valve

Primary Outcomes

Actuarial freedom from reoperation due to Structural Valve Deterioration
time frame: 10 years

Secondary Outcomes

Actuarial survival rate
time frame: 10 years
Freedom from valve related death
time frame: 10 years
Freedom from structural valve deterioration
time frame: 10 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients implanted for less than 9 months, or candidate for implantation with a St Jude Medical 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.

Additional Information

Official title Trifecta Durability Study
Principal investigator Sven Lehmann
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.