Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02562404

Enrollment

100

Registered

2015-09-29

Start date

2015-04-30

Completion date

2016-12-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Gastrointestinal Tract, Radiofrequency Catheter Ablation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Symptoms Associated with Vagus Nerve Injury	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.

Countries

United States

Outcome results