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| Name | Class |
|---|---|
| Maastricht University Medical Center | OTHER |
| Radboud University Medical Center | OTHER |
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Rationale:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ablation success | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence of AF or atrial arrhythmia after the blanking period | 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. | 3 months |
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Inclusion Criteria:
Exclusion criteria
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All eligible patients scheduled for AF ablation of at the MUMC+ and Radboudumc will be asked to participate in this cohort study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique VM Verhaert, MD | Contact | +31 24 30 92470 | dominique.verhaert@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Ulrich Schotten, MD PhD | Maastricht University, departments of physiology and cardiology | Study Chair |
| Kevin Vernooy, MD PhD | Maastricht UMC+ and Radboudumc, department of cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525 GA Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36773038 | Derived | 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. |
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| Disease progression to persistent or permanent AF. | 24 months |
| Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. | 12 months |
| Use of antiarrhythmic drugs (AADs) one year after ablation. | 12 months |
| Number of veins with pulmonary vein reconnection at redo procedure. | 24 months |
| Maastricht UMC+ | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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