TY - JOUR
T1 - Efficacy of LGE-MRI-guided fibrosis ablation versus conventional catheter ablation of atrial fibrillation
T2 - The DECAAF II trial: Study design
AU - The DECAAF II Investigators
AU - Marrouche, Nassir F.
AU - Greene, Tom
AU - Dean, J. Michael
AU - Kholmovski, Eugene G.
AU - Boer, Leonie Morrison de
AU - Mansour, Moussa
AU - Calkins, Hugh
AU - Marchlinski, Francis
AU - Wilber, David
AU - Hindricks, Gerhard
AU - Mahnkopf, Christian
AU - Jais, Pierre
AU - Sanders, Prashanthan
AU - Brachmann, Johannes
AU - Bax, Jereon
AU - Dagher, Lilas
AU - Wazni, Oussama
AU - Akoum, Nazem
N1 - Funding Information:
The study was supported by Medtronic, Boston Scientific, Biosense Webster, Abbott, Siemens, and GE.
Funding Information:
: Dr Marrouche reports having received consulting fees from Biosense Webster, as well as research funding from Abbot. Dr Marrouche also reports having a family member as the CEO of Cardiac Designs. Dr. Kholmovski has equity interest in Marrek, Inc. and has received consultant's fees from Marrek, Inc. Dr. Calkins reports having received consulting fees and/or honoraria from Biosense Webster, Atricure, Boston Scientific, Ablacon, Abbot medical, and Medtronic. Dr Marchlinski reports having received research grant support from Biosense Webster and being on the scientific advisory board of Biosense Webster, Medtronic, and Abbot Medical. Dr Sanders reports having served on the advisory board of Medtronic, Abbott Medical, Boston Scientific, CathRx and PaceMate. Dr Sanders reports that the University of Adelaide has received on his behalf lecture and/or consulting fees from Medtronic, Abbott Medical, and Boston Scientific. Dr Sanders reports that the University of Adelaide has received on his behalf research funding from Medtronic, Abbott Medical, Boston Scientific, and Microport. Dr Sanders is supported by a Practitioner Fellowship from the National Health and Medical Research Council of Australia and by the National Heart Foundation of Australia. Dr Wilber reports having received research funding from Abbott, Atricure, and Biosense Webster, as well as consulting fees from ACCF, Biosense Webster and Boston Scientific. All other co‐authors report no relevant conflict of interest. Disclosures
Publisher Copyright:
© 2021 Wiley Periodicals LLC
PY - 2021/4
Y1 - 2021/4
N2 - 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.
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.
KW - cardiac magnetic resonance imaging
KW - fibrosis-guided ablation
KW - persistent atrial fibrillation
UR - http://www.scopus.com/inward/record.url?scp=85101932548&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101932548&partnerID=8YFLogxK
U2 - 10.1111/jce.14957
DO - 10.1111/jce.14957
M3 - Article
C2 - 33600025
AN - SCOPUS:85101932548
SN - 1045-3873
VL - 32
SP - 916
EP - 924
JO - Journal of cardiovascular electrophysiology
JF - Journal of cardiovascular electrophysiology
IS - 4
ER -