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NCT00431834 · ClinicalTrials.gov registry record · Phase 3
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
A Phase 3 study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT00431834 is a Phase 3 study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 75 participants.
The verdict
NCT00431834, a Phase 3 study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.
Interventions
- PROCEDURE Surgical RF Ablation
- DEVICE Cardioblate System Surgical Ablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00431834
The ClinicalTrials.gov registry entry for NCT00431834 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Surgical RF Ablation is the first listed.
NCT00431834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00431834 about?
NCT00431834 is a clinical study titled "Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study". This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes p...
What is the current status of trial NCT00431834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2007-05. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00431834?
The interventions under investigation include: Surgical RF Ablation (PROCEDURE), Cardioblate System Surgical Ablation System (DEVICE).
Who is sponsoring clinical trial NCT00431834?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
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