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NCT03016975 · ClinicalTrials.gov registry record · NA
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
A NA study, sponsored by Edwards Lifesciences.
- Terminated
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT03016975: Clinical Trial NA study, sponsored by Edwards Lifesciences.
NCT03016975 is a NA study that was terminated before completion, run by Edwards Lifesciences. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03016975, a NA study, was terminated before completion, sponsored by Edwards Lifesciences.
- TERMINATED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
Primary Outcome
Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).
Interventions
- DEVICE Edwards Cardioband System
- DRUG Guideline Directed Medical Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2022-09-20 |
| Phase | NA |
Why NCT03016975 stopped before completion
NCT03016975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Edwards Cardioband System is the first listed.
NCT03016975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03016975 about?
NCT03016975 is a clinical study titled "Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)". To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
What is the current status of trial NCT03016975?
This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2017-06-01. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT03016975?
The interventions under investigation include: Edwards Cardioband System (DEVICE), Guideline Directed Medical Therapy (DRUG).
Who is sponsoring clinical trial NCT03016975?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03016975's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 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
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