Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02321514 · ClinicalTrials.gov registry record · NA
Expanded Clinical Study of the Tendyne Mitral Valve System
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 191
- Enrollment target
NCT02321514: Completed NA study, sponsored by Abbott Medical Devices.
NCT02321514 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 191 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02321514, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 191 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
Primary Outcome
Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC): * Cardiovascular death * Reintervention caused by valve-related dysfunction * Disabling stroke * Myocardial infarction (MI) * Life-threatening bleeding (BARC Type 2, 3, and 5) * Major Vascular Complications * Renal failure requiring dialysis * Other device-related SAEs * Other procedure-related SA
Interventions
- DEVICE Tendyne Mitral Valve System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2014-11 |
| Est. Completion | 2025-04 |
| Phase | NA |
What the finished NCT02321514 record still lists
NCT02321514 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Tendyne Mitral Valve System is the first listed.
NCT02321514 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02321514 about?
NCT02321514 is a clinical study titled "Expanded Clinical Study of the Tendyne Mitral Valve System". The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise...
What is the current status of trial NCT02321514?
This trial is currently completed. It is a NA study. The enrollment target is 191 participants. The study started on 2014-11. Estimated completion is 2025-04.
What interventions are being tested in trial NCT02321514?
The interventions under investigation include: Tendyne Mitral Valve System (DEVICE).
Who is sponsoring clinical trial NCT02321514?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02321514's enrollment target sits among peer trials
191 574th of 2000 higher than 1,427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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
- NCT04621435 · 191 participants · Phase 1
Imaging of Solid Tumors Using FAP-2286
- NCT06810544 · 191 participants · Phase 1
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
- NCT01492972 · 192 participants · Phase 3
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
- NCT01973881 · 192 participants
Quantitative MRI for Myelofibrosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia