Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

Intermountain Health Care, Inc.

Status: Completed

Conditions: Gastrointestinal Tract; Atrial Fibrillation; Radiofrequency Catheter Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT02562404

1025037

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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