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NCT00903370 · ClinicalTrials.gov registry record · Phase 2
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
A Phase 2 study, sponsored by Annetine Gelijns.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT00903370 is a Phase 2 study that has completed, run by Annetine Gelijns. The registered enrollment target is 260 participants.
The verdict
NCT00903370, a Phase 2 study, has completed, sponsored by Annetine Gelijns.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deaden atrial heart tissue and block electrical signals that may be causing your heart to beat irregularly. There are no new procedures being tested in this study; both mitral valve surgery and surgical ablation are used regularly in patients who have mitral valve problems and atrial fibrillation, although no surgical ablation devices have been approved by the Food and Drug Administration for the treatment of atrial fibrillation. What is not known with certainty, is whether patients with atrial fibrillation who are having planned mitral valve surgery would do better if they also had surgical ablation rather than medication alone to treat their atrial fibrillation.
Interventions
- DEVICE Ablation
- PROCEDURE MVS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2010-01 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00903370
The ClinicalTrials.gov registry entry for NCT00903370 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annetine Gelijns, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ablation is the first listed.
NCT00903370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00903370 about?
NCT00903370 is a clinical study titled "Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery". The purpose of the research is to determine whether treating atrial fibrillation with surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to deade...
What is the current status of trial NCT00903370?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2010-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00903370?
The interventions under investigation include: Ablation (DEVICE), MVS (PROCEDURE).
Who is sponsoring clinical trial NCT00903370?
This trial is sponsored by Annetine Gelijns, which has 4 total clinical trials registered on ClinicalTrials.gov.
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