Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

NCT02562404 | Completed

• 1 other identifier: 1025037
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Gastrointestinal Tract; Radiofrequency Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84143, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• T. Jared Bunch, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 29, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 3, 2017

Record last verified: 2016-06

Locations

US (1)