Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by Abbott Medical Devices.
NCT01593917 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 329 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 regurgitatio
Interventions
- DEVICE Trifecta™ Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 329 participants |
| Start Date | 2012-07-02 |
| Est. Completion | 2019-09-26 |
What the finished NCT01593917 record still lists
NCT01593917 is an observational study that tracks outcomes without assigning an intervention. The registered 329 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Trifecta™ Valve is the first listed.
NCT01593917 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06036446 · 329 participants · NA
LATe Cerclage in High-risk Pregnancies (LATCH)
- NCT00359684 · 330 participants
Use of Cysteamine in the Treatment of Cystinosis
- NCT03817502 · 330 participants · Phase 3
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
- NCT03922724 · 330 participants · Phase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI