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NCT00514735 · ClinicalTrials.gov registry record · Phase 3
Tailored Treatment of Permanent Atrial Fibrillation
A Phase 3 study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
NCT00514735: Completed Phase 3 study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00514735 is a Phase 3 study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 210 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00514735, a Phase 3 study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
Primary Outcome
The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included: 1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes. 2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only) 3. The Investigator
Interventions
- PROCEDURE Medtronic Cardiac Ablation System
- DRUG Class I or III Antiarrhythmic Medications
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-11 |
| Phase | Phase 3 |
What the finished NCT00514735 record still lists
NCT00514735 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Medtronic Cardiac Ablation System is the first listed.
NCT00514735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00514735 about?
NCT00514735 is a clinical study titled "Tailored Treatment of Permanent Atrial Fibrillation". The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.
What is the current status of trial NCT00514735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2007-05. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00514735?
The interventions under investigation include: Medtronic Cardiac Ablation System (PROCEDURE), Class I or III Antiarrhythmic Medications (DRUG).
Who is sponsoring clinical trial NCT00514735?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00514735's enrollment target sits among peer trials
210 1338th of 2000 higher than 656 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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