Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-005229
NCT ID: NCT04659213
About this study
The purpose of this study is to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male or female age ≥ 22 years and < 80 years.
- Clinical decision to proceed with AF ablation procedure.
- Ablation procedure to be completed with General Anesthesia.
- Ablation procedure to be completed with use of radiofrequency catheter ablation.
Exclusion Criteria:
- History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
- Presence of a pH probe deployed in the esophagus.
- Planned AF ablation procedure to be completed with laser energy or with cryo-energy.
- Acute or uncontrolled psychiatric illness.
- Unable to undergo upper endoscopy.
- Enrollment in another FDA clinical trial.
- Unstable medical condition(s) that precludes safely completing study protocol.
- Subject is incarcerated.
- Subject is pregnant.
- Subject is unable to comprehend the details of the study.
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ammar Killu, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available