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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02562404
Other study ID # 1025037
Secondary ID
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
Health authority
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:

Study Design


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
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