Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation (DECAAFII)
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|ClinicalTrials.gov Identifier: NCT02529319|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2015
Last Update Posted : August 25, 2020
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.
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 ). 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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Fibrosis||Procedure: MRI-Guided Ablation Procedure: Conventional Ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation: The DECAAF II Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: MRI-Guided Ablation
Patients will undergo catheter ablation using DE-MRI as a guide for fibrosis imaging.
Procedure: MRI-Guided Ablation
Catheter ablation of AF will be guided by a DE-MRI of the patient's heart prior to the procedure.
Active Comparator: Conventional Ablation
Patients will undergo conventional catheter ablation as described by the HRS guidelines.
Procedure: Conventional Ablation
Catheter ablation of AF using pulmonary vein isolation (PVI) will be performed using the HRS guidelines.
- AF Recurrence [ Time Frame: 18 months ]recurrence of 30 seconds of any atrial arrythmia as evidenced by a 45 second ECG strip.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529319
|United States, Utah|
|CARMA Center, University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Nassir Marrouche, MD, FHRS||Associate Professor|