Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT04063761
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (age over 18 years)
* Undergoing first left atrial ablation for the treatment of atrial fibrillation (AF) including pulmonary vein isolation
* Undergoing catheter-based ablation procedure using radiofrequency energy
* Patients must be able to understand and critically review the informed consent form.
* Subjects must understand and agree to study requirements and sign a written informed consent.
Exclusion Criteria:
* Patients who are unable to provide informed consent.
* History of prior atrial fibrillation (AF) ablation procedures.
* Significant co-morbidities that preclude standard ablation procedure.
* Patients with \<40 kg of body mass
* Patients with relevant esophageal pathology (e.g. esophageal cancer)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04063761
Study Brief:
Protocol Section:
NCT04063761