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, Dominique V.M.

AU - Linz, Dominik

AU - Chaldoupi, Sevasti Maria

AU - Westra, Sjoerd W.

AU - den Uijl, Dennis W.

AU - Philippens, Suzanne

AU - Kerperien, Mijke

AU - Habibi, Zarina

AU - Vorstermans, Bianca

AU - ter Bekke, Rachel M.A.

AU - Beukema, Rypko J.

AU - Evertz, Reinder

AU - Hemels, Martin E.W.

AU - Luermans, Justin G.L.M.

AU - Manusama, Randolph

AU - Lankveld, Theo A.R.

AU - van der Heijden, Claudia A.J.

AU - Bidar, Elham

AU - Hermans, Ben J.M.

AU - Zeemering, Stef

AU - Bijvoet, Geertruida P.

AU - Habets, Jesse

AU - Holtackers, Robert J.

AU - Mihl, Casper

AU - Nijveldt, Robin

AU - van Empel, Vanessa P.M.

AU - Knackstedt, Christian

AU - Simons, Sami O.

AU - Buhre, Wolfgang F.F.A.

AU - Tijssen, Jan G.P.

AU - Isaacs, Aaron

AU - Crijns, Harry J.G.M.

AU - Maesen, Bart

AU - Vernooy, Kevin

AU - Schotten, Ulrich

N1 - 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

Y1 - 2022

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 - atrial fibrillation ablation

KW - catheter ablation

KW - prediction model

KW - pulmonary vein isolation

KW - study design

KW - translational research

UR - http://www.scopus.com/inward/record.url?scp=85134706609&partnerID=8YFLogxK

U2 - 10.3389/fcvm.2022.879139

DO - 10.3389/fcvm.2022.879139

M3 - Journal article

C2 - 35879962

AN - SCOPUS:85134706609

VL - 9

JO - Frontiers in Cardiovascular Medicine

JF - Frontiers in Cardiovascular Medicine

SN - 2297-055X

M1 - 879139

ER -