NCT05381805

ISOLATION 2.0: a Multicenter Clinical Care and Research Platform

Intensive (Pre)Clinical Characterization of Patients undergOing Atrial fibrillATion ablatlON: a Multicenter Clinical Care and Research Platform

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Treatment recommendations and guidelines for patients with atrial fibrillation (AF) are continuously changing. The role of catheter ablation in the treatment of AF increases and the techniques of the procedures are improving unceasingly. Responding to and evaluating the effect of these changes requires careful examination of this patient population and procedure outcomes. The aim is to create a clinical characterization platform for patients scheduled for AF ablations with the purpose to optimize health care processes and related translational research.

Detailed description

Study design: Prospective cohort study and research platform of patients referred for AF ablation. Clinical characteristics and results of routine tests and procedures before, during and after AF ablation are collected. In addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extECG), extended rhythm monitoring, biomarker testing, genetic analysis, and questionnaires. In subgroups of patients transesophageal electrocardiogram (TE-ECG), epicardial electroanatomical mapping and/or left atrial appendage (LAA) biopsy is performed.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2022-08-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2022-05-19
• Last updated: 2022-05-19