Trifecta™ Long Term Follow-Up (LTFU) Study

Aortic Valve Stenosis Clinical Trial

Official title:

Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593917
• Other study ID #: 1104
• Status: Completed
• Start date: July 2, 2012
• Est. completion date: September 26, 2019

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Incompetence
• Aortic Valve Insufficiency
• Aortic Valve Regurgitation
• Aortic Valve Stenosis

Intervention

Device:
• Trifecta™ Valve
Aortic valve replacement with the Trifecta™ aortic bioprosthesis.

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Mission Health & Hospitals	Asheville	North Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	USC University Hospital	Los Angeles	California
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Intermountain Salt Lake Cardiovascular and Thoracic Surgery	Salt Lake City	Utah
United States	Main Line Health Center/Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Late Adverse Events Per 100 Patient-Years of Follow-up	Late adverse events are defined those occurring from 31 days through 10 years post-implant. This outcome measure is calculated by dividing the number of late adverse events of each type by the total number of patient-years of follow-up accumulated from 31 days through 10 years post-implant, expressed in hundreds of years.	31 days through 10 years post-implant
Other	Participants' Average Mean Transvalvular Gradient at 10 Years Post-implant by Valve Size	Average of participants' mean aortic transvalvular pressure gradient measured by echocardiography at 10 years post-implant. Averages are reported for each valve size separately. The mean transvalvular pressure gradient is the mean difference in pressure between the inlet side and outlet side of the aortic valve during systole, measured in millimeters of mercury (mmHg).	10 years post-implant
Other	Participants' Mean Aortic Effective Orifice Area (EOA) Measurement at 10 Years Post-Implant by Valve Size	Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve estimated by echocardiography. Mean EOA in square centimeters is reported separately for each valve size.	10 years post-implant
Other	Number of Participants by Aortic Valvular Regurgitation Grade at 10 Years Post-Implant	Regurgitation occurs when the aortic valve does not fully seal, allowing backflow of blood through the closed valve. The amount of aortic regurgitation in this study was graded as none, trivial, mild, moderate or severe by echocardiographic assessment. Moderate or severe aortic regurgitation can cause symptoms of heart failure, such as fatigue, shortness of breath and exercise intolerance.	10 years post-implant
Other	Number of Participants by New York Heart Association (NYHA) Functional Class, Preoperatively and at 10 Years Post-Implant	The New York Heart Association (NYHA) functional classification system relates heart failure symptoms to everyday activities and the patient's quality of life.; Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath).; Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea.; Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.; Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.	Preoperative through 10 years
Primary	Percentage of Participants With Freedom From Reoperation for Structural Valve Deterioration at 10 Years Post-Implant	Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve implantation 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 post-implant
Secondary	Percentage of Participants With Freedom From All-Cause Mortality at 10 Years Post-Implant	Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.	10 years post-implant
Secondary	Percentage of Participants With Freedom From Valve-Related Mortality at 10 Years Post-Implant	Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.	10 years post-implant
Secondary	Percentage of Participants With Freedom From Structural Valve Deterioration at 10 Years Post-Implant	Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, 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. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.	10 years post-implant