Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation (ISOLATION)

Maastricht University

Status: Unknown

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

Treatments: Procedure: Pulmonary vein isolation

Study type: Observational

Funder types: Other

Identifiers

NCT04342312

NL70787.068.19

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.