Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation (ISOLATION)
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|ClinicalTrials.gov Identifier: NCT04342312|
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 5, 2020
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.
To identify predictors of success of AF ablation including clinical factors, AF recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background.
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.
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Atrial Fibrillation Paroxysmal Atrial Fibrillation, Persistent||Procedure: Pulmonary vein isolation|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study|
|Actual Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||May 1, 2023|
|Estimated Study Completion Date :||May 1, 2024|
- Procedure: 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 Names:
- atrial fibrillation ablation
- AF ablation
- Ablation success [ Time Frame: 12 months ]
Ablation success is defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted.
Atrial arrhythmias are AF, atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on ECG or Holter monitoring.
- Time to recurrence of AF or atrial arrhythmia after the blanking period [ Time Frame: 24 months ]
- Early recurrences of AF or atrial arrhythmia, defined as any episode of AF AT or non-isthmus dependent AFl during the blanking period. [ Time Frame: 3 months ]
- Disease progression to persistent or permanent AF. [ Time Frame: 24 months ]
- Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. [ Time Frame: 12 months ]
- Use of antiarrhythmic drugs (AADs) one year after ablation. [ Time Frame: 12 months ]
- Number of veins with pulmonary vein reconnection at redo procedure. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342312
|Contact: Dominique VM Verhaert, MD||+31 24 30 firstname.lastname@example.org|
|Nijmegen, Gelderland, Netherlands, 6525 GA Nijmegen|
|Contact: Dominique VM Verhaert, MD|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Contact: Dominique VM Verhaert, MD|
|Study Chair:||Ulrich Schotten, MD PhD||Maastricht University, departments of physiology and cardiology|
|Study Chair:||Kevin Vernooy, MD PhD||Maastricht UMC+ and Radboudumc, department of cardiology|