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Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562404
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.

Condition or disease
Atrial Fibrillation Gastrointestinal Tract Radiofrequency Catheter Ablation

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vagus Nerve Injury Post Radiofrequency Catheter Ablation for Atrial Fibrillation (Vagus Nerve Study)
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562404


Locations
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United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
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Principal Investigator: T. Jared Bunch, MD Intermountain Medical Center
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02562404    
Other Study ID Numbers: 1025037
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: June 2016
Additional relevant MeSH terms:
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Vagus Nerve Injuries
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Vagus Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries