Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

• Conditions: Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent

• Registration Number: NCT04342312
• Lead Sponsor: Maastricht University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-05
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05
• Primary Completion: 2023-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion 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

• Serious patient condition before ablation;
• Physically or mentally unable to provide written informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ablation success	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.

Secondary Outcome Measures

Name	Time	Method
Disease progression to persistent or permanent AF.	24 months
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
Use of antiarrhythmic drugs (AADs) one year after ablation.	12 months
Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification.	12 months
Number of veins with pulmonary vein reconnection at redo procedure.	24 months

Trial Locations

Locations (2)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands