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

Dominique V M Verhaert; Dominik Linz; Sevasti Maria Chaldoupi; Sjoerd W Westra; Dennis W den Uijl; Suzanne Philippens; Mijke Kerperien; Zarina Habibi; Bianca Vorstermans; Rachel M A Ter Bekke; Rypko J Beukema; Reinder Evertz; Martin E W Hemels; Justin G L M Luermans; Randolph Manusama; Theo A R Lankveld; Claudia A J van der Heijden; Elham Bidar; Ben J M Hermans; Stef Zeemering; Geertruida P Bijvoet; Jesse Habets; Robert J Holtackers; Casper Mihl; Robin Nijveldt; Vanessa P M van Empel; Christian Knackstedt; Sami O Simons; Wolfgang F F A Buhre; Jan G P Tijssen; Aaron Isaacs; Harry J G M Crijns; Bart Maesen; Kevin Vernooy; Ulrich Schotten

doi:10.3389/fcvm.2022.879139

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

Front Cardiovasc Med. 2022 Jun 30:9:879139. doi: 10.3389/fcvm.2022.879139. eCollection 2022.

Authors

Dominique V M Verhaert^{1

2}, Dominik Linz^{1

2

3

4}, Sevasti Maria Chaldoupi², Sjoerd W Westra¹, Dennis W den Uijl², Suzanne Philippens², Mijke Kerperien¹, Zarina Habibi^{1

2}, Bianca Vorstermans², Rachel M A Ter Bekke², Rypko J Beukema¹, Reinder Evertz¹, Martin E W Hemels¹, Justin G L M Luermans^{1

2}, Randolph Manusama², Theo A R Lankveld², Claudia A J van der Heijden⁵, Elham Bidar⁵, Ben J M Hermans^{2

6}, Stef Zeemering⁶, Geertruida P Bijvoet^{1

2}, Jesse Habets⁷, Robert J Holtackers^{8

9}, Casper Mihl⁸, Robin Nijveldt¹, Vanessa P M van Empel², Christian Knackstedt², Sami O Simons¹⁰, Wolfgang F F A Buhre¹¹, Jan G P Tijssen¹², Aaron Isaacs⁶, Harry J G M Crijns², Bart Maesen⁵, Kevin Vernooy^{1

2}, Ulrich Schotten⁶

Affiliations

¹ Department of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.
² Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, Netherlands.
³ Centre for Heart Rhythm Disorders, Royal Adelaide Hospital, The University of Adelaide, Adelaide, SA, Australia.
⁴ Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
⁵ Department of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, Netherlands.
⁶ Department of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, Netherlands.
⁷ Department of Medical Imaging, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.
⁸ Department of Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, Netherlands.
⁹ School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.
¹⁰ Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, Netherlands.
¹¹ Department of Anesthesiology, Maastricht University Medical Center, Maastricht, Netherlands.
¹² Department of Cardiology, Amsterdam University Medical Center (UMC), Amsterdam, Netherlands.

Abstract

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.

Keywords: atrial fibrillation; atrial fibrillation ablation; catheter ablation; prediction model; pulmonary vein isolation; study design; translational research.

Copyright © 2022 Verhaert, Linz, Chaldoupi, Westra, den Uijl, Philippens, Kerperien, Habibi, Vorstermans, ter Bekke, Beukema, Evertz, Hemels, Luermans, Manusama, Lankveld, van der Heijden, Bidar, Hermans, Zeemering, Bijvoet, Habets, Holtackers, Mihl, Nijveldt, van Empel, Knackstedt, Simons, Buhre, Tijssen, Isaacs, Crijns, Maesen, Vernooy and Schotten.