Efficacy of LGE‐MRI‐guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design

Autor: Oussama M. Wazni, Moussa Mansour, Gerhard Hindricks, Johannes Brachmann, Tom Greene, Francis E. Marchlinski, Hugh Calkins, Nassir F. Marrouche, Prashanthan Sanders, Lilas Dagher, Eugene G. Kholmovski, Nazem Akoum, David J. Wilber, Christian Mahnkopf, J. Michael Dean, Pierre Jaïs, Leonie Morrison-de Boer, Jereon Bax, Decaaf Ii Investigators
Rok vydání: 2021
Předmět:
medicine.medical_specialty
guided ablation
medicine.medical_treatment
cardiac magnetic resonance imaging
Contrast Media
Gadolinium
Catheter ablation
030204 cardiovascular system & hematology
03 medical and health sciences
0302 clinical medicine
Recurrence
Cardiac magnetic resonance imaging
Physiology (medical)
Multicenter trial
Internal medicine
Atrial Fibrillation
Clinical endpoint
Humans
Medicine
Prospective Studies
cardiovascular diseases
030212 general & internal medicine
Atrial tachycardia
medicine.diagnostic_test
business.industry
Atrial fibrillation
Ablation
medicine.disease
Fibrosis
Magnetic Resonance Imaging
fibrosis‐
persistent atrial fibrillation
Treatment Outcome
Pulmonary Veins
Catheter Ablation
cardiovascular system
Cardiology
medicine.symptom
Cardiology and Cardiovascular Medicine
business
Atrial flutter
Zdroj: Journal of Cardiovascular Electrophysiology, 32(4), 916-924. WILEY
ISSN: 1540-8167
1045-3873
0252-9319
DOI: 10.1111/jce.14957
Popis: Introduction 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.
Databáze: OpenAIRE
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