Intensive (pre)clinical characterization of patientS undergOing atriaL fibrillATion ablatION: a multicenter clinical care and research platform

Recruiting

• Conditions: atrial arrhythmia; Atrial fibrillation; 10007593

• Registration Number: NL-OMON53906
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1963

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Ablation success, defined as freedom from documented recurrence of atrial<br /><br>arrhythmia after 12 months. Recurrences in the first 3 months after the index<br /><br>procedure (blanking period) are exempted.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Time to recurrence of AF or other atrial arrhythmia after the blanking period.<br /><br>• Early recurrences of AF or other atrial arrhythmia, defined as any episode of<br /><br>documented arrhythmia during the blanking period.<br /><br>• Disease progression to persistent or permanent AF.<br /><br>• Use of antiarrhythmic drugs (AADs) one year after ablation.<br /><br>• Changes in circulating biomarkers and non-invasive electrophysiological<br /><br>markers for substrate quantification.<br /><br>• Redo procedures, defined as repeated ablation procedure with the goal to<br /><br>prevent recurrence of AF or reduce the AF burden after one or more previous<br /><br>attempts to achieve the same goal.<br /><br>• Number of veins with pulmonary vein reconnection at redo procedure.<br /><br>• Major adverse cardiovascular events (MACE).<br /><br>• Procedure times, defined as skin-to-skin time (time from initial femoral vein<br /><br>puncture to time of removal of sheaths).</p><br>