Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
NCT ID: NCT04342312
Last Updated: 2020-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-03-05
2024-05-01
Brief Summary
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Although there are several individual factors which are known to influence the chances of successful atrial fibrillation (AF) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty.
Objectives:
To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.
Study design:
Prospective registry of patients undergoing AF ablation. Clinical characteristics and results of routine tests are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.
Study population:
Patients aged 18 years and older with documented AF, scheduled for AF ablation.
Main study endpoints:
Ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pulmonary vein isolation
Participation in this study does not influence the choice of ablation technique. Usually, cryoballoon ablation is chosen for patients with paroxysmal AF and no previous ablations. Radiofrequency ablation is often used for redo procedures or for patients with persistent AF. Hybrid ablations are most applied in persistent AF patients. However, physicians may deviate from these standard approaches for a variety of reasons, including personal experience or preference.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented atrial fibrillation;
* Scheduled for AF ablation or redo AF ablation;
* Able and willing to provide written informed consent.
Exclusion Criteria
* Physically or mentally unable to provide written informed consent.
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Radboud University Medical Center
OTHER
Maastricht University
OTHER
Responsible Party
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Principal Investigators
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Ulrich Schotten, MD PhD
Role: STUDY_CHAIR
Maastricht University, departments of physiology and cardiology
Kevin Vernooy, MD PhD
Role: STUDY_CHAIR
Maastricht UMC+ and Radboudumc, department of cardiology
Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Maastricht UMC+
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Dominique VM Verhaert, MD
Role: primary
Dominique VM Verhaert, MD
Role: primary
References
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Betz K, Verhaert DVM, Gawalko M, Hermans ANL, Habibi Z, Pluymaekers NAHA, van der Velden RMJ, Homberg M, Philippens S, Hereijgers MJM, Vorstermans B, Simons SO, den Uijl DW, Chaldoupi SM, Luermans JGLM, Westra SW, Lankveld T, van Steenwijk RP, Hol B, Schotten U, Vernooy K, Hendriks JM, Linz D. Atrial fibrillation-specific refinement of the STOP-Bang sleep apnoea screening questionnaire: insights from the Virtual-SAFARI study. Clin Res Cardiol. 2023 Jun;112(6):834-845. doi: 10.1007/s00392-023-02157-9. Epub 2023 Feb 11.
Other Identifiers
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NL70787.068.19
Identifier Type: -
Identifier Source: org_study_id
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