Status:
COMPLETED
Esophageal Deviation in Atrial Fibrillation Ablation
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior wall of the left atrium...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- A maximum of up to 54 patients will be enrolled in this prospective single-center single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent AF) will be included in this study. Consistent with the current definitions, paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent AF, is defined as ≥1 documented AF lasting \>1week in duration or lasting less than 7 days but requiring electrical or pharmacological cardioversion to sinus rhythm.
- Age \>18 - Age \< 80 yr
- Documentation of atrial fibrillation (AF)
- 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 (international normalized ratio) \> 4.0 at the time of the procedure
- History of (H/o) of severe esophageal ulcers, strictures, varices, bleeding, laceration or perforation, esophagitis
- Severe Gastroesophageal Reflux Disease (GERD)
- H/o esophageal surgery or any esophageal banding or cautery
- H/o chest radiation
- 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 (Human Chorionic Gonadotropin) test within 7 days prior to procedure
- Presence of left atrial thrombus
Exclusion
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03261973
Start Date
November 17 2017
End Date
June 15 2020
Last Update
June 30 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114