Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

The Cleveland Clinic93 enrolled

Overview

This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Esophageal Lesion

Interventions

PillCam ESO Capsule EndoscopeDIAGNOSTIC_TEST

Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation * Adults aged 18 years and older * Patients able to give informed consent Exclusion Criteria: * Patients under the age of 18 * Patient unable to or unwilling to swallow the capsule endoscopes * Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices * Pregnant or lactating females * Subjects with history of abdominal, pelvic, or bowel surgery within the past year

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy

Time frame: 14 days

Secondary Outcomes

Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA

Time frame: 14 Days

Data from ClinicalTrials.gov

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