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

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...

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Publicado en:Journal of Cardiovascular Electrophysiology Vol. 32; no. 4; pp. 916 - 925
Autores principales: Marrouche, Nassir F., Greene, Tom, Dean, J. Michael, Kholmovski, Eugene G., Boer, Leonie Morrison‐de, 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
Formato: diagnostic images research tables/charts Journal Article
Publicado: Wiley-Blackwell Apr2021
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Wiley-Blackwell
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        atl: Efficacy of LGE‐MRI‐guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation: The DECAAF II trial: Study design.
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        au:
          Marrouche, Nassir F.
          Greene, Tom
          Dean, J. Michael
          Kholmovski, Eugene G.
          Boer, Leonie Morrison‐de
          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
        affil: Department of Cardiology, Tulane University School of Medicine, New Orleans Louisiana,, USA
      sug:
        subj:
          Magnetic Resonance Imaging Methods
          Fibrosis Therapy
          Ablation Techniques Methods
          Catheter Ablation
          Atrial Fibrillation Therapy
          Patient Safety
          Treatment Outcomes
          Human
          Pulmonary Veins Surgery
          Smartphone Utilization
          Electrocardiography
          Secondary Analysis
          Descriptive Statistics
          Cox Proportional Hazards Model
      ab: 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.
      pubtype: Academic Journal
      doctype:
        diagnostic images
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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