Trifecta™ Durability Study

NCT01256710 | Terminated Results

• 1 other identifier: CS-10-012-EU-TV
• Study Type: observational
• Target: 1,151
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Actuarial Freedom From All-cause Mortality

  10 years

• Freedom From Valve Related Mortality

  10 years

• Freedom From Structural Valve Deterioration

  10 years

Study Arms (1)

Trifecta™ Valve Group

Subjects implanted with the Trifecta™ aortic bioprosthesis.

Device: Trifecta™ aortic bioprosthesis

Interventions

Trifecta™ aortic bioprosthesis DEVICE

Surgical aortic valve replacement with the Trifecta™ valve.

Trifecta™ Valve Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Universitat Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Yunlong (Phil) Zhang, MD, MS, Clinical Consultant
• Organization: Abbott Medical Devices, Structure Heart Valves

phil.yl.zhang@abbott.com

669-203-9308

Study Officials

• Sven Lehmann

  Universitat Herzzentrum Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: January 1, 2011
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)