Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Gastrointestinal Tract Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiofrequency Catheter Ablation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Murray, Utah, 84143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Symptoms Associated with Vagus Nerve Injury

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

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.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 29, 2015
Registry last updated: Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed