atrial arrhythmia Atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • 18 years of age or older; • Documented atrial fibrillation; • Referred for any type of AF ablation: catheter ablation, stand-alone surgical AF ablation, surgical AF ablation concomitant with cardiac surgery, hybrid AF ablation, or redo AF ablation; • Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Conditions preventing the patient from adhering from the study protocol; • Emergency procedures. A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG-imaging is asked: • Severe allergic reaction against contrast agents used in the CT- or MRI-protocol • Severe allergic reaction against body surface electrodes A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked: • Status after esophageal or gastric surgery A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for Cardiovascular Magnetic Resonance (ISOLATION CMR) is asked: • Contraindication to MRI A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for concomitant hybrid ablation of atrial fibrillation (COMBAT-AF) is asked: • Prior catheter or surgical AF ablation. Specific exclusion criteria for epicardial mapping (only applicable for patients undergoing hybrid or surgical AF ablation): • COPD Gold II, III, or IV; • Heart failure, currently in NYHA class III or IV; • Any other pulmonary, cardiac, or other condition that may compromise a safe conduct of epicardial mapping in the opinion of the treating physician or investigator, taking the prolonged duration of single lung ventilation into account.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Ablation success, 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time to recurrence of AF or other atrial arrhythmia after the blanking period. • Early recurrences of AF or other atrial arrhythmia, defined as any episode of documented arrhythmia during the blanking period. • Disease progression to persistent or permanent AF. • Use of antiarrhythmic drugs (AADs) one year after ablation. • Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. • Redo procedures, defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal. • Number of veins with pulmonary vein reconnection at redo procedure. • Major adverse cardiovascular events (MACE). • Procedure times, defined as skin-to-skin time (time from initial femoral vein puncture to time of removal of sheaths). | — |
Countries
Netherlands
Outcome results
None listed