Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Atrial Fibrillation Gastrointestinal Tract Radiofrequency Catheter Ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.