Rationale and Design of the ISOLATION Study: A Multicenter Prospective Cohort Study Identifying Predictors for Successful Atrial Fibrillation Ablation in an Integrated Clinical Care and Research Pathway

Frontiers in Cardiovascular Medicine

article

Dominique V. M. Verhaert¹  Dominik Linz¹  Sevasti Maria Chaldoupi²  Sjoerd W. Westra¹  Dennis W. den Uijl²  Suzanne Philippens²  Mijke Kerperien¹  Zarina Habibi¹  Bianca Vorstermans²  Rachel M. A. ter Bekke²  Rypko J. Beukema¹  Reinder Evertz¹  Martin E. W. Hemels¹  Justin G. L. M. Luermans¹  Randolph Manusama²  Theo A. R. Lankveld²  Claudia A. J. van der Heijden⁵  Elham Bidar⁵  Ben J. M. Hermans²  Stef Zeemering⁶  Geertruida P. Bijvoet¹  Jesse Habets⁷  Robert J. Holtackers⁸  Casper Mihl⁸  Robin Nijveldt¹  Vanessa P. M. van Empel²  Christian Knackstedt²  Sami O. Simons^1,10  Wolfgang F. F. A. Buhre^1,11  Jan G. P. Tijssen^1,12  Aaron Isaacs⁶  Harry J. G. M. Crijns²  Bart Maesen⁵  Kevin Vernooy¹  Ulrich Schotten⁶ 

[1] Department of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre;Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre;Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, The University of Adelaide;Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen;Department of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center;Department of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University;Department of Medical Imaging, Radboud Institute for Health Sciences, Radboud University Medical Center;Department of Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center;School of Biomedical Engineering and Imaging Sciences, King’s College London;Department of Respiratory Medicine, Maastricht University Medical Center;Department of Anesthesiology, Maastricht University Medical Center;Department of Cardiology, Amsterdam University Medical Center

关键词: atrial fibrillation;    catheter ablation;    pulmonary vein isolation;    atrial fibrillation ablation;    study design;    translational research;    prediction model;   

DOI  :  10.3389/fcvm.2022.879139

学科分类：地球科学(综合)

来源: Frontiers

【 摘 要 】

Introduction Continuous progress in atrial fibrillation (AF) ablation techniques has led to an increasing number of procedures with improved outcome. However, about 30–50% of patients still experience recurrences within 1 year after their ablation. Comprehensive translational research approaches integrated in clinical care pathways may improve our understanding of the complex pathophysiology of AF and improve patient selection for AF ablation. Objectives Within the “IntenSive mOlecular and eLectropathological chAracterization of patienTs undergoIng atrial fibrillatiOn ablatioN” (ISOLATION) study, we aim to identify predictors of successful AF ablation in the following domains: (1) clinical factors, (2) AF patterns, (3) anatomical characteristics, (4) electrophysiological characteristics, (5) circulating biomarkers, and (6) genetic background. Herein, the design of the ISOLATION study and the integration of all study procedures into a standardized pathway for patients undergoing AF ablation are described. Methods ISOLATION ( NCT04342312 ) is a two-center prospective cohort study including 650 patients undergoing AF ablation. Clinical characteristics and routine clinical test results will be collected, as well as results from the following additional diagnostics: determination of body composition, pre-procedural rhythm monitoring, extended surface electrocardiogram, biomarker testing, genetic analysis, and questionnaires. A multimodality model including a combination of established predictors and novel techniques will be developed to predict ablation success. Discussion In this study, several domains will be examined to identify predictors of successful AF ablation. The results may be used to improve patient selection for invasive AF management and to tailor treatment decisions to individual patients.

【 授权许可】

CC BY