Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

Intermountain Health Care, Inc.100 enrolled

Overview

This study is an observational study designed to determine the extent of gastrointestinal (GI) post-procedure complications after Radiofrequency Catheter Ablation (RFCA) for atrial fibrillation (AF). This exploratory study will evaluate patient symptoms prior to the RFCA procedure, at 1 month post RFCA procedure, and at 3 months post RFCA procedure, through the administration of a questionnaire. The purpose of this study is to determine if vagus nerve injury resulting from RFCA for AF increases the risk of post-procedure GI complications that may present as temporary or permanent symptoms.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Atrial Fibrillation Gastrointestinal Tract Radiofrequency Catheter Ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a verified medical history of atrial fibrillation. * Male or female \>18 years of age. * Patients scheduled for an RFCA procedure, subsequent to failure of one Antiarrhythmic Drug (AAD class I, III or IV), or ablation. * Ability to answer questions posed by the questionnaire. * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. Exclusion Criteria: * None

Outcomes

Primary Outcomes

Symptoms Associated with Vagus Nerve Injury

The composite of symptoms associated with vagus nerve injury: increased heart rate, bloating, early satiety, heartburn, changes in bowel habits, weight loss, problems with swallowing, nausea and vomiting. These symptoms will be discovered through the administration of a questionnaire.

Time frame: At RFCA procedure, 1 month post RFCA procedure, 3 months post RFCA procedure