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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT01546168
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 - Age \< 80 yr
* Documentation of atrial fibrillation (AF)
* Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
* General anesthesia
* All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.
Exclusion Criteria:
* Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
* INR \> 4.0 at the time of the procedure
* H/o of severe esophageal ulcers, strictures, esophagitis or GERD
* H/o Esophageal Surgery
* Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
* Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
* Significant abnormality on Swallowing Impairment Score
* Mental impairment precluding signing consent or completing follow up
* Patients with any other significant uncontrolled or unstable medical condition
* Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01546168
Study Brief:
Protocol Section:
NCT01546168