Brief Title
Trifecta™ Long Term Follow-Up (LTFU) Study
Official Title
Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
Brief Summary
The Trifecta™ LTFU Study is a single-arm, multi-center, prospective, non-randomized, post-market study conducted in the United States and Canada to collect long-term safety and effectiveness data through 10 years after implant of the Trifecta™ aortic bioprosthetic valve. The Trifecta™ is a tri-leaflet stented pericardial valve designed for supraannular placement in the aortic position. The Trifecta™ LTFU Study is an extension of the Trifecta™ Investigational Device Exemption (IDE) Study (NCT00475709) conducted to support United States Food and Drug Administration (FDA) approval of the Trifecta™ valve. All Trifecta™ LTFU Study subjects received Trifecta™ valve implants during participation in the Trifecta™ IDE study and subsequently consented to extended annual follow-up through 10 years under the Trifecta™ LTFU protocol.
Detailed Description
This clinical study was designed as an extension of the Trifecta™ IDE Study supporting FDA approval of the Trifecta™ valve. A total of 11 Trifecta™ IDE Study investigational sites in the United States (n=9) and Canada (n=2) participated in the Trifecta™ LTFU Study. Study enrollment included 329 subjects implanted from 2007 through 2009 at these 11 sites during the IDE Study who consented to participate in continued annual follow-up through 10 years post-implant. Of these 329 subjects, 140 also participated in the FDA-mandated Trifecta™ Post-Approval Study (PAS, NCT01514162) prior to consenting to additional annual follow-up under the Trifecta™ LTFU protocol. The remaining 189 subjects entered the Trifecta™ LTFU Study directly from the Trifecta™ IDE Study. The Trifecta™ LTFU Study database subsumes all data collected in the 329 participants under the Trifecta™ IDE and Trifecta™ PAS protocols and extends these data through 10 years from each subject's original date of implant in the Trifecta™ IDE Study. The Trifecta™ LTFU Study data thus encompass 10 years of continuous annual post-implant follow-up in the 329 participants as well as their pre-implant Baseline Visit data. Data collected includes adverse events, assessments of heart failure symptoms by New York Heart Association (NYHA) functional classification, and echocardiographic assessments of Trifecta™ valve function.
Study Type
Observational
Primary Outcome
Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
Secondary Outcome
Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
Condition
Aortic Valve Insufficiency
Intervention
Trifecta™ Valve
Study Arms / Comparison Groups
Subjects previously implanted with a Trifecta™ valve in the Trifecta™ IDE Study
Description: Subjects enrolled in this clinical study were implanted with the Trifecta™ aortic bioprosthetic valve during 2007, 2008 and 2009 as part of the Trifecta™ IDE Study conducted to obtain FDA approval.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
329
Start Date
July 2, 2012
Completion Date
September 26, 2019
Primary Completion Date
September 26, 2019
Eligibility Criteria
Inclusion Criteria: 1. Patient currently has a Trifecta™ aortic valve that was implanted at one of the U.S. or Canadian investigational sites during the Trifecta™ IDE study. 2. Patient met eligibility criteria prior to enrollment in the Trifecta™ IDE study. 3. Patient agrees to complete all required follow-up visits. 4. Patient provided written informed consent prior to any study related procedure, as approved by the governing Institutional Review Board (IRB) or the Ethics Committee (EC) of the investigational site. Exclusion Criteria: 1. Patient is currently participating or planning to participate in any other study unless approved by the Sponsor.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Angelic Roach, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01593917
Organization ID
1104
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Angelic Roach, Study Director, Abbott Medical Devices
Verification Date
January 2021