Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jun 30:9:879139.
doi: 10.3389/fcvm.2022.879139. eCollection 2022.

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  1   2 , Dominik Linz  1   2   3   4 , Sevasti Maria Chaldoupi  2 , Sjoerd W Westra  1 , Dennis W den Uijl  2 , Suzanne Philippens  2 , Mijke Kerperien  1 , Zarina Habibi  1   2 , Bianca Vorstermans  2 , Rachel M A Ter Bekke  2 , Rypko J Beukema  1 , Reinder Evertz  1 , Martin E W Hemels  1 , Justin G L M Luermans  1   2 , Randolph Manusama  2 , Theo A R Lankveld  2 , Claudia A J van der Heijden  5 , Elham Bidar  5 , Ben J M Hermans  2   6 , Stef Zeemering  6 , Geertruida P Bijvoet  1   2 , Jesse Habets  7 , Robert J Holtackers  8   9 , Casper Mihl  8 , Robin Nijveldt  1 , Vanessa P M van Empel  2 , Christian Knackstedt  2 , Sami O Simons  10 , Wolfgang F F A Buhre  11 , Jan G P Tijssen  12 , Aaron Isaacs  6 , Harry J G M Crijns  2 , Bart Maesen  5 , Kevin Vernooy  1   2 , Ulrich Schotten  6
Affiliations

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 et al. Front Cardiovasc Med. .

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.

PubMed Disclaimer

Conflict of interest statement

CM received consultancy fees for Bayer Healthcare. SS received grants from Boehringer Ingelheim, AstraZeneca and GlaxoSmithKline, honorary fees for presentations from AstraZeneca and Chiesi, consultancy fees from GlaxoSmithKline, payment for advisory boards from Chiesi and GlaxoSmithKline, all outside the submitted work, and payed to his institution. KV was consultant for Medtronic, Abbott, Philips, Biosense Webster. US received consultancy fees or honoraria from Università della Svizzera Italiana (USI, Switzerland), Roche Diagnostics (Switzerland), EP Solutions Inc. (Switzerland), Johnson & Johnson Medical Limited (United Kingdom), Bayer Healthcare (Germany). US was co-founder and shareholder of YourRhythmics BV, a spin-off company of the University Maastricht. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
The 6 domains of interest in which predictors for successful atrial fibrillation ablation are sought: (1) clinical risk factors, (2) pre-procedural AF patterns, (3) anatomical characteristics, (4) electrophysiological characteristics, (5) circulating biomarkers, and (6) genetic background. AF, atrial fibrillation; CT, computed tomography; ECG, electrocardiogram; MRI, magnetic resonance imaging. Study procedures with an asterisk are conducted for a subset of patients.
FIGURE 2
FIGURE 2
Flowchart of the standardized, integrated clinical care and research pre- and post AF ablation pathway. Structure of the pre- and post AF ablation pathway and general recommendations for the type of AF ablation. Treating physicians may choose to deviate from these recommendations depending on specific patient characteristics of patient preference. *Thoracocopic/hybrid ablation is strongly considered if LAVi >5− ml/m2 or in case of patient preference. AF, atrial fibrillation; LAVi, left atrial volume index; RF, radiofrequency.
FIGURE 3
FIGURE 3
Integration of clinical diagnostics and study procedures in the work-up before (A) and the follow-up after (B) AF ablation. Procedures in white are standard clinical procedures, procedures in black are added for research purposes. *When applicable (in case of epicardial or hybrid ablation). AF, atrial fibrillation; BMI, body mass index; CMR, cardiac magnetic resonance imaging; CT, computed tomography; ECG, electrocardiogram; extECG, extended surface electrocardiogram; LAA, left atrial appendage; MoCa, Montreal Cognitive Assessment.
See this image and copyright information in PMC

References

    1. Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, et al. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham heart study: a cohort study. Lancet. (2015) 386:154–62. 10.1016/S0140-6736(14)61774-8 - DOI - PMC - PubMed
    1. Staerk L, Sherer JA, Ko D, Benjamin EJ, Helm RH. Atrial fibrillation: epidemiology, pathophysiology, and clinical outcomes. Circ Res. (2017) 120:1501–17. 10.1161/CIRCRESAHA.117.309732 - DOI - PMC - PubMed
    1. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, et al. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the european association of cardio-thoracic surgery (EACTS). Eur Heart J. (2021) 42:373–498. 10.1093/eurheartj/ehaa612 - DOI - PubMed
    1. Ganesan AN, Shipp NJ, Brooks AG, Kuklik P, Lau DH, Lim HS, et al. Long-term outcomes of catheter ablation of atrial fibrillation: a systematic review and meta-analysis. J Am Heart Assoc. (2013) 2:e004549. 10.1161/JAHA.112.004549 - DOI - PMC - PubMed
    1. van der Heijden CAJ, Vroomen M, Luermans JG, Vos R, Crijns H, Gelsomino S, et al. Hybrid versus catheter ablation in patients with persistent and longstanding persistent atrial fibrillation: a systematic review and meta-analysis. Eur J Cardiothorac Surg. (2019) 56:433–43. 10.1093/ejcts/ezy475 - DOI - PubMed

LinkOut - more resources