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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: Completed Phase 3 study, sponsored by Medtronic Cardiovascular.
NCT00431834 is a Phase 3 study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subject's heart rhythm was evaulated by wearing a Holter Monitor for 24 hours.
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 |
What the finished NCT00431834 record still lists
NCT00431834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgical RF Ablation is the first listed.
NCT00431834 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00431834's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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