Trifecta Durability Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01256710
• Collaborator: (none)
• Enrollment: 1,231
• Location: 1
• Actual Duration (Months): 122.3
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disorder	Device: Implantation of the Trifecta Valve

Study Design

• Study Type: Observational
• Actual Enrollment: 1231 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Trifecta Durability Study
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 12, 2021
• Actual Study Completion Date: Mar 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Trifecta Valve Group	Device: Implantation of the Trifecta Valve; Implantation of the bioprothesis valve, Trifecta Valve

Outcome Measures

Primary Outcome Measures

1. Actuarial freedom from reoperation due to Structural Valve Deterioration [10 years]

Secondary Outcome Measures

1. Actuarial survival rate [10 years]

2. Freedom from valve related death [10 years]

3. Freedom from structural valve deterioration [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitat Herzzentrum Leipzig	Leipzig		Germany	04289

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Sven Lehmann, Universitat Herzzentrum Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01256710
• Other Study ID Numbers: CS-10-012-EU-TV
• First Posted: Dec 8, 2010
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of Jul 20, 2021