Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562404
• Other study ID #: 1025037
• Status: Completed
• Phase: N/A
• First received: September 25, 2015
• Last updated: March 2, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Atrial Fibrillation
• Gastrointestinal Tract
• Radiofrequency Catheter Ablation

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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