NCT04342312

Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation

Intensive Molecular and Electropathological Characterization of patientS undergOing atriaL fibrillATion ablatION: a Multicenter Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein isolation	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.

Timeline

• Start date: 2020-03-05
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2020-04-13
• Last updated: 2020-05-05

Locations

2 sites across 1 country: Netherlands