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NCT01362738 · ClinicalTrials.gov registry record · Phase 3
Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation
A Phase 3 study, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT01362738: Completed Phase 3 study, sponsored by Texas Cardiac Arrhythmia Research Foundation.
NCT01362738 is a Phase 3 study that has completed, run by Texas Cardiac Arrhythmia Research Foundation. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362738, a Phase 3 study, has completed, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is superior to the standard approach alone in enhancing the long-term success rate of catheter ablation in persistent or long-standing persistent atrial fibrillation (AF) patients.
Primary Outcome
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting \>30 seconds at follow-up
Interventions
- PROCEDURE RFCA of PV and extra-PV triggers
- PROCEDURE LAA isolation along with the conventional ablation strategy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT01362738 record still lists
NCT01362738 is an interventional study that assigns participants to a tested intervention. The registered 156 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which RFCA of PV and extra-PV triggers is the first listed.
NCT01362738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362738 about?
NCT01362738 is a clinical study titled "Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation". The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is superior to the standard approach alone in enhancing the long-term succ...
What is the current status of trial NCT01362738?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2010-11. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01362738?
The interventions under investigation include: RFCA of PV and extra-PV triggers (PROCEDURE), LAA isolation along with the conventional ablation strategy (PROCEDURE).
Who is sponsoring clinical trial NCT01362738?
This trial is sponsored by Texas Cardiac Arrhythmia Research Foundation, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01362738's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 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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