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Efficacy of LGE‐MRI‐guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design
Author(s) -
Marrouche Nassir F.,
Greene Tom,
Dean J. Michael,
Kholmovski Eugene G.,
Boer Leonie Morrisonde,
Mansour Moussa,
Calkins Hugh,
Marchlinski Francis,
Wilber David,
Hindricks Gerhard,
Mahnkopf Christian,
Jais Pierre,
Sanders Prashanthan,
Brachmann Johannes,
Bax Jereon,
Dagher Lilas,
Wazni Oussama,
Akoum Nazem
Publication year - 2021
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.14957
Subject(s) - medicine , atrial fibrillation , catheter ablation , ablation , cardiology , atrial tachycardia , atrial flutter , pulmonary vein , clinical endpoint , multicenter trial , randomized controlled trial , hazard ratio , pericardial effusion , prospective cohort study , confidence interval , multicenter study
Success rates of catheter ablation in persistent atrial fibrillation (AF) remain suboptimal. A better and more targeted ablation strategy is urgently needed to optimize outcomes of AF treatment. We sought to assess the safety and efficacy of targeting atrial fibrosis during ablation of persistent AF patients in improving procedural outcomes. Methods The DECAAF II trial (ClinicalTrials. gov identifier number NCT02529319) is a prospective, randomized, multicenter trial of patients with persistent AF. Patients with persistent AF undergoing a first‐time ablation procedure were randomized in a 1:1 fashion to receive conventional pulmonary vein isolation (PVI) ablation (Group 1) or PVI + fibrosis‐guided ablation (Group 2). Left atrial fibrosis and ablation induced scarring were defined by late gadolinium enhancement magnetic resonance imaging at baseline and at 3–12 months postablation, respectively. The primary endpoint is the recurrence of atrial arrhythmia postablation, including atrial fibrillation, atrial flutter, or atrial tachycardia after the 90‐day postablation blanking period. Patients were followed for a period of 12–18 months with a smartphone ECG Device (ECG Check Device, Cardiac Designs Inc.). With an anticipated enrollment of 900 patients, this study has an 80% power to detect a 26% reduction in the hazard ratio of the primary endpoint. Results and Conclusion The DECAAF II trial is the first prospective, randomized, multicenter trial of patients with persistent AF using imaging defined atrial fibrosis as a treatment target. The trial will help define an optimal approach to catheter ablation of persistent AF, further our understanding of influencers of ablation lesion formation, and refine selection criteria for ablation based on atrial myopathy burden.