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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 is a NA study that has completed, run by Tulane University School of Medicine. The registered enrollment target is 843 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02529319
The ClinicalTrials.gov registry entry for NCT02529319 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 843 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University School of Medicine, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MRI-Guided Ablation is the first listed.
NCT02529319 reports 0 study locations.
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.
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