Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Studieoversigt
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott Northwestern Hospital Cardiac Surgical Associates
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt Heart Institute
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Utah
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Murray, Utah, Forenede Stater, 84157
- Intermountain Heart & Lung Surgical Associates
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Subject currently participating in another device or drug study
- Subject unable or unwilling to return for study follow-up visits
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Trifecta Valve Group
Subjects implanted with a Trifecta valve.
|
surgical replacement of aortic valve
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Late Adverse Event Incidence
Tidsramme: 5 years
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Characterize Patient NYHA Functional Classification Status
Tidsramme: 5 years
|
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. |
5 years
|
|
Report the Hemodynamic Performance of the Valve
Tidsramme: 5 years
|
Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size. |
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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