Clinical trial NCT01593917: Trifecta™ Long Term Follow-Up (LTFU) Study
Official title: Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Insufficiency
Aortic Valve Regurgitation
Aortic Valve Stenosis
Aortic Valve Incompetence
Keywords: Aortic valve
Heart valve
Tissue valve
Bioprosthesis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously implanted with a Trifecta prosthetic 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.

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.

Primary outcomes:
measure: Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant
timeFrame: 10 years post-implant
Secondary outcomes:
measure: Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant
timeFrame: 10 years post-implant
measure: Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant
timeFrame: 10 years post-implant
measure: Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant
timeFrame: 10 years post-implant
Other outcomes:
measure: Number of Late Adverse Events Per 100 Patient-Years of Follow-up
timeFrame: 31 days through 10 years post-implant
measure: Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size
timeFrame: 10 years post-implant
measure: Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size
timeFrame: 10 years post-implant
measure: Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant
timeFrame: 10 years post-implant
measure: Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant
timeFrame: Preoperative through 10 years
Locations:
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Health Center/Lankenau Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Intermountain Salt Lake Cardiovascular and Thoracic Surgery
state: Utah
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Quebec
country: Canada
facility: Institut de Cardiologie de Quebec (HÃ´pital Laval)
Study officials:
affiliation: Abbott Structural Heart
name: Barathi Sethuraman
role: STUDY_DIRECTOR
References:
citation: Bavaria JE, Desai ND, Cheung A, Petracek MR, Groh MA, Borger MA, Schaff HV. The St Jude Medical Trifecta aortic pericardial valve: results from a global, multicenter, prospective clinical study. J Thorac Cardiovasc Surg. 2014 Feb;147(2):590-7. doi: 10.1016/j.jtcvs.2012.12.087. Epub 2013 Mar 7.
citation: Goldman S, Cheung A, Bavaria JE, Petracek MR, Groh MA, Schaff HV. Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve. J Thorac Cardiovasc Surg. 2017 Mar;153(3):561-569.e2. doi: 10.1016/j.jtcvs.2016.09.089. Epub 2016 Nov 18.