TY - JOUR
T1 - Rationale and Design of the ISOLATION Study:
T2 - A Multicenter Prospective Cohort Study Identifying Predictors for Successful Atrial Fibrillation Ablation in an Integrated Clinical Care and Research Pathway
AU - Verhaert, D.V.M.
AU - Linz, D.
AU - Chaldoupi, S.M.
AU - Westra, S.W.
AU - den Uijl, D.W.
AU - Philippens, S.
AU - Kerperien, M.
AU - Habibi, Z.
AU - Vorstermans, B.
AU - ter Bekke, R.M.A.
AU - Beukema, R.J.
AU - Evertz, R.
AU - Hemels, M.E.W.
AU - Luermans, J.G.L.M.
AU - Manusama, R.
AU - Lankveld, T.A.R.
AU - van der Heijden, C.A.J.
AU - Bidar, E.
AU - Hermans, B.M.
AU - Zeemering, S.
AU - Bijvoet, G.P.
AU - Habets, J.
AU - Holtackers, R.J.
AU - Mihl, C.
AU - Nijveldt, R.
AU - van Empel, V.P.M.
AU - Knackstedt, C.
AU - Simons, S.O.
AU - Buhre, W.F.F.A.
AU - Tijssen, J.G.P.
AU - Isaacs, A.
AU - Crijns, H.J.G.M.
AU - Maesen, B.
AU - Vernooy, K.
AU - Schotten, U.
N1 - Funding Information:
This study and the analysis of the collected material is supported by grants of the Dutch Heart Foundation (CVON2014-09, RACE V Reappraisal of Atrial Fibrillation: Interaction between hypercoagulability, Electrical remodeling, and Vascular Destabilization in the Progression of AF) and the European Commission (ITN Network Personalize AF: Personalized Therapies for Atrial Fibrillation: a translational network, grant no. 860974; CATCH ME: Characterizing Atrial fibrillation by Translating its Causes into Health Modifiers in the Elderly, grant no. 633196; MAESTRIA: Machine Learning Artificial Intelligence Early Detection Stroke Atrial Fibrillation, grant no. 965286).
Publisher Copyright:
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.
PY - 2022/6/30
Y1 - 2022/6/30
N2 - 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
AB - 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
KW - atrial fibrillation
KW - catheter ablation
KW - pulmonary vein isolation
KW - atrial fibrillation ablation
KW - study design
KW - translational research
KW - prediction model
U2 - 10.3389/fcvm.2022.879139
DO - 10.3389/fcvm.2022.879139
M3 - Article
C2 - 35879962
SN - 2297-055X
VL - 9
JO - Frontiers in Cardiovascular Medicine
JF - Frontiers in Cardiovascular Medicine
M1 - 879139
ER -