Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation (Vagus Nerve Study)

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Radiofrequency Catheter Ablation; Gastrointestinal Tract

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84143
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation patients at the Intermountain Medical Center Heart Rhythm Clinic who are candidates for Radiofrequency Catheter Ablation (RFCA) will be screened for participation in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At RFCA procedure, 1 month post RFCA procedure, 3 months post RFCA procedure

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: T. Jared Bunch, MD, Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Arrhythmias, Cardiac; Cranial Nerve Diseases; Vagus Nerve Diseases; Cranial Nerve Injuries; Atrial Fibrillation; Vagus Nerve Injuries
• Other Study ID Numbers: 1025037