Intensive molecular and electropathological characterization of patientS undergOing atriaL fibrillATion ablatION: a multicenter prospective cohort study

Recruiting

• Conditions: atrial arrhythmia; Atrial fibrillation; 10007521; 10007593

• Registration Number: NL-OMON52886
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

In order to be eligible to participate in this registry, a subject must meet
all of the following criteria:
• 18 years of age or older;
• Documented atrial fibrillation;
• Scheduled for 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 registry:
• Serious patient condition before ablation;
• Emergency procedures.

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:
• Known esophageal disease;
• Previous surgery on esophagus, throat or stomach;
• Recent (<4 weeks) myocardial infarction;
• Unwilling to provide additional informed consent.

Epicardial mapping is only performed in the subset of patients undergoing
hybrid ablation or surgical ablation. A subject who meets any of the following
criteria will be excluded for this additional procedure:
• 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>The primary endpoint is ablation success, defined as freedom from documented<br /><br>recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3<br /><br>months after the index procedure (blanking period) are exempted.<br /><br>Atrial arrhythmias are defined as AF, atrial tachycardia (AT) and non-isthmus<br /><br>dependent atrial flutter (AFl). Following the current guidelines, episodes of<br /><br>atrial arrhythmia should be documented on ECG, on Holter monitoring (minimum<br /><br>duration of 30 seconds), or on an implanted device (atrial high rate episode<br /><br>during at least 5 minutes or mode switch, and confirmed as being AF or other<br /><br>atrial arrhythmia by a trained physician).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Time to recurrence of atrial arrhythmia after the blanking period.<br /><br>• Time to recurrence of AF after the blanking period.<br /><br>• Early AF recurrences, defined as any episode of AF during the blanking period.<br /><br>• Early recurrences of atrial arrhythmia, defined as any episode of AF, AT or<br /><br>non-isthmus dependent AFl during the blanking period.<br /><br>• Changes in circulating biomarkers and non-invasive electrophysiological<br /><br>markers for substrate quantification.<br /><br>• Use of antiarrhythmic drugs (AADs) one year after ablation.<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).</p><br>