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

IntroductionContinuous 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 inte...

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Main Authors: 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
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-06-01
Series:Frontiers in Cardiovascular Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2022.879139/full
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author Dominique V. M. Verhaert
Dominique V. M. Verhaert
Dominik Linz
Dominik Linz
Dominik Linz
Dominik Linz
Sevasti Maria Chaldoupi
Sjoerd W. Westra
Dennis W. den Uijl
Suzanne Philippens
Mijke Kerperien
Zarina Habibi
Zarina Habibi
Bianca Vorstermans
Rachel M. A. ter Bekke
Rypko J. Beukema
Reinder Evertz
Martin E. W. Hemels
Justin G. L. M. Luermans
Justin G. L. M. Luermans
Randolph Manusama
Theo A. R. Lankveld
Claudia A. J. van der Heijden
Elham Bidar
Ben J. M. Hermans
Ben J. M. Hermans
Stef Zeemering
Geertruida P. Bijvoet
Geertruida P. Bijvoet
Jesse Habets
Robert J. Holtackers
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
Kevin Vernooy
Ulrich Schotten
author_facet Dominique V. M. Verhaert
Dominique V. M. Verhaert
Dominik Linz
Dominik Linz
Dominik Linz
Dominik Linz
Sevasti Maria Chaldoupi
Sjoerd W. Westra
Dennis W. den Uijl
Suzanne Philippens
Mijke Kerperien
Zarina Habibi
Zarina Habibi
Bianca Vorstermans
Rachel M. A. ter Bekke
Rypko J. Beukema
Reinder Evertz
Martin E. W. Hemels
Justin G. L. M. Luermans
Justin G. L. M. Luermans
Randolph Manusama
Theo A. R. Lankveld
Claudia A. J. van der Heijden
Elham Bidar
Ben J. M. Hermans
Ben J. M. Hermans
Stef Zeemering
Geertruida P. Bijvoet
Geertruida P. Bijvoet
Jesse Habets
Robert J. Holtackers
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
Kevin Vernooy
Ulrich Schotten
author_sort Dominique V. M. Verhaert
collection DOAJ
description IntroductionContinuous 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.ObjectivesWithin 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.MethodsISOLATION (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.DiscussionIn 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.
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spelling doaj.art-a4857046cedb4b3ba1db6f6b80b721a52022-12-22T01:25:35ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-06-01910.3389/fcvm.2022.879139879139Rationale 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 PathwayDominique V. M. Verhaert0Dominique V. M. Verhaert1Dominik Linz2Dominik Linz3Dominik Linz4Dominik Linz5Sevasti Maria Chaldoupi6Sjoerd W. Westra7Dennis W. den Uijl8Suzanne Philippens9Mijke Kerperien10Zarina Habibi11Zarina Habibi12Bianca Vorstermans13Rachel M. A. ter Bekke14Rypko J. Beukema15Reinder Evertz16Martin E. W. Hemels17Justin G. L. M. Luermans18Justin G. L. M. Luermans19Randolph Manusama20Theo A. R. Lankveld21Claudia A. J. van der Heijden22Elham Bidar23Ben J. M. Hermans24Ben J. M. Hermans25Stef Zeemering26Geertruida P. Bijvoet27Geertruida P. Bijvoet28Jesse Habets29Robert J. Holtackers30Robert J. Holtackers31Casper Mihl32Robin Nijveldt33Vanessa P. M. van Empel34Christian Knackstedt35Sami O. Simons36Wolfgang F. F. A. Buhre37Jan G. P. Tijssen38Aaron Isaacs39Harry J. G. M. Crijns40Bart Maesen41Kevin Vernooy42Kevin Vernooy43Ulrich Schotten44Department of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsCentre for Heart Rhythm Disorders, Royal Adelaide Hospital, The University of Adelaide, Adelaide, SA, AustraliaDepartment of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, NetherlandsDepartment of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, NetherlandsDepartment of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Medical Imaging, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, NetherlandsDepartment of Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, NetherlandsSchool of Biomedical Engineering and Imaging Sciences, King’s College London, London, United KingdomDepartment of Radiology and Nuclear Medicine, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, Netherlands0Department of Respiratory Medicine, Maastricht University Medical Center, Maastricht, Netherlands1Department of Anesthesiology, Maastricht University Medical Center, Maastricht, Netherlands2Department of Cardiology, Amsterdam University Medical Center (UMC), Amsterdam, NetherlandsDepartment of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Cardiothoracic Surgery, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht, NetherlandsDepartment of Cardiology, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, NetherlandsDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Centre, Maastricht, NetherlandsDepartment of Physiology, Cardiovascular Research Institute Maastricht, Maastricht University, Maastricht, NetherlandsIntroductionContinuous 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.ObjectivesWithin 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.MethodsISOLATION (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.DiscussionIn 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.https://www.frontiersin.org/articles/10.3389/fcvm.2022.879139/fullatrial fibrillationcatheter ablationpulmonary vein isolationatrial fibrillation ablationstudy designtranslational research
spellingShingle Dominique V. M. Verhaert
Dominique V. M. Verhaert
Dominik Linz
Dominik Linz
Dominik Linz
Dominik Linz
Sevasti Maria Chaldoupi
Sjoerd W. Westra
Dennis W. den Uijl
Suzanne Philippens
Mijke Kerperien
Zarina Habibi
Zarina Habibi
Bianca Vorstermans
Rachel M. A. ter Bekke
Rypko J. Beukema
Reinder Evertz
Martin E. W. Hemels
Justin G. L. M. Luermans
Justin G. L. M. Luermans
Randolph Manusama
Theo A. R. Lankveld
Claudia A. J. van der Heijden
Elham Bidar
Ben J. M. Hermans
Ben J. M. Hermans
Stef Zeemering
Geertruida P. Bijvoet
Geertruida P. Bijvoet
Jesse Habets
Robert J. Holtackers
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
Kevin Vernooy
Ulrich Schotten
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
atrial fibrillation
catheter ablation
pulmonary vein isolation
atrial fibrillation ablation
study design
translational research
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic atrial fibrillation
catheter ablation
pulmonary vein isolation
atrial fibrillation ablation
study design
translational research
url https://www.frontiersin.org/articles/10.3389/fcvm.2022.879139/full
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