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NCT01593917 · ClinicalTrials.gov registry record
Trifecta™ Long Term Follow-Up (LTFU) Study
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 329
- Enrollment target
NCT01593917 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 329 participants.
The verdict
NCT01593917 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 329 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Trifecta™ Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2012-07-02 |
| Est. Completion | 2019-09-26 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01593917
The ClinicalTrials.gov registry entry for NCT01593917 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 329 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trifecta™ Valve is the first listed.
NCT01593917 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01593917 about?
NCT01593917 is a clinical study titled "Trifecta™ Long Term Follow-Up (LTFU) Study". 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-leafl...
What is the current status of trial NCT01593917?
This trial is currently completed. The enrollment target is 329 participants. The study started on 2012-07-02. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT01593917?
The interventions under investigation include: Trifecta™ Valve (DEVICE).
Who is sponsoring clinical trial NCT01593917?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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