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NCT02529319 · ClinicalTrials.gov registry record · NA
Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation
A NA study, sponsored by Tulane University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 843
- Enrollment target
NCT02529319: Completed NA study, sponsored by Tulane University School of Medicine.
NCT02529319 is a NA study that has completed, run by Tulane University School of Medicine. The registered enrollment target is 843 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02529319, a NA study, has completed, sponsored by Tulane University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 843 participants
- Enrollment target
Study Summary
This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome. OBJECTIVES: Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome of DECAAF II. Patients will be randomized to receive conventional pulmonary vein isolation (PVI) ablation or PVI + fibrosis-guided ablation. The investigators will follow patients longitudinally to assess the primary outcome identified as recurrence of persistent atrial arrhythmias (AA) (atrial fibrillation, atrial flutter or atrial tachycardia as defined by recent guidelines \[2\]). The investigators hypothesize that patients receiving fibrosis-guided ablation in addition to conventional PVI ablation will have fewer AA recurrences than those who receive PVI ablation alone. The investigators will also examine the efficacy of the fibrosis-guided ablation intervention on a number of secondary or exploratory outcomes including the individual components of the primary outcome (atrial fibrillation, atrial flutter and atrial tachycardia), symptomatic atrial arrhythmia, AF cycle length/regularity/termination, cardiovascular (CV)-related hospitalization, CV-related mortality, quality of life measurements (University of Toronto Atrial Fibrillation Severity Scale (AFSS), and AF burden. The safety of the two interventions will be evaluated by evaluating peri-procedural complications including stroke, peripheral vascular stenosis, bleeding, esophageal injury, cardiac perforation, heart failure, and death.
Primary Outcome
recurrence of 30 seconds of any atrial arrythmia as evidenced by a 45 second ECG strip.
Interventions
- PROCEDURE MRI-Guided Ablation
- PROCEDURE Conventional Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 843 participants |
| Start Date | 2016-07 |
| Est. Completion | 2021-04-21 |
| Phase | NA |
What the finished NCT02529319 record still lists
NCT02529319 is an interventional study that assigns participants to a tested intervention. The registered 843 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which MRI-Guided Ablation is the first listed.
NCT02529319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02529319 about?
NCT02529319 is a clinical study titled "Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation". This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome. OBJECTIVES: Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue...
What is the current status of trial NCT02529319?
This trial is currently completed. It is a NA study. The enrollment target is 843 participants. The study started on 2016-07. Estimated completion is 2021-04-21.
What interventions are being tested in trial NCT02529319?
The interventions under investigation include: MRI-Guided Ablation (PROCEDURE), Conventional Ablation (PROCEDURE).
Who is sponsoring clinical trial NCT02529319?
This trial is sponsored by Tulane University School of Medicine, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02529319's enrollment target sits among peer trials
843 132nd of 2000 higher than 1,868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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