Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
1 other identifier
interventional
245
1 country
6
Brief Summary
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 20, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
May 31, 2017
CompletedFebruary 15, 2019
January 1, 2019
2.7 years
January 17, 2012
October 14, 2016
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late Adverse Event Incidence
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
5 years
Secondary Outcomes (2)
Characterize Patient NYHA Functional Classification Status
5 years
Report the Hemodynamic Performance of the Valve
5 years
Study Arms (1)
Trifecta Valve Group
EXPERIMENTALSubjects implanted with a Trifecta valve.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
- Subject met eligibility criteria of IDE study
- Subject agrees to complete study follow-up visits
- Subject provides written informed consent
You may not qualify if:
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Abbott Northwestern Hospital Cardiac Surgical Associates
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Heart Institute
Nashville, Tennessee, 37232, United States
Intermountain Heart & Lung Surgical Associates
Murray, Utah, 84157, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Johnson
- Organization
- St Jude Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2012
First Posted
January 20, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 15, 2019
Results First Posted
May 31, 2017
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share