Long Term Follow Up Study of the St. Jude Medical Trifecta Valve
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000032
NCT ID: NCT01593917
Sponsor Protocol Number: 15-000032
About this study
The purpose of this study is to collect long term follow up study data of the Trifecta valve in subjects who had the Trifecta valve implanted during the IDE study.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Currently has a Trifecta valve that was implanted
- Met eligibility criteria prior to enrollment in the Trifecta IDE study
- Agrees to complete all required follow-up visits
- Provided written informed consent prior to any study related procedure as approved by the governing Institutional Review Board or the Ethics Committee of the investigational site
Exclusion Criteria
- Is currently participating or planning to participate in any other study unless approved by St Jude Medical
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hartzell Schaff, M.D. |
Closed for enrollment |
|
More information
Publications
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To evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve.
Read More on PubMed
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The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic performance of the Trifecta valve.
Read More on PubMed