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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04079634
Eligibility Criteria:
Inclusion Criteria:
1. Patients above the age of 18 years old.
2. Patients with the diagnosis of atrial fibrillation undergoing clinically indicated de-novo AF ablation procedure.
3. Patients must be willing to provide informed consent.
Exclusion Criteria:
1. Patients with contraindication to EGD.
2. History of prior AF ablation procedures.
3. Significant co-morbidities that preclude standard ablation procedure.
4. Patient is ineligible for EnsoETM placement due to:
* Known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia).
* Known ingestion of acidic or caustic poisons within the prior 24 hours.
* Patients with \<40 kg of body mass.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04079634
Study Brief:
Protocol Section:
NCT04079634