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Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"

NCT01396356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2013-01-10

No results posted yet for this study

Summary

You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation. Complications of ablation procedures include damage to structures near the heart from the heat energy used during the ablation procedure. These complications include damage to the esophagus (the tube through which food passes when you swallow) and stomach. A rare but often fatal complication resulting from severe heat damage is called an atrio-esophageal fistula (an abnormal connection between the heart and esophagus). However, the frequency of minimal damage to the esophagus or nerves of the gut that may go unnoticed are not known.

This study is designed to determine how often atrial fibrillation ablation causes problems with the stomach and esophagus.

Conditions

  • Atrial Fibrillation Ablation Procedure

Interventions

PROCEDURE

GI procedures

If you agree to participate in the study, you will undergo a series of tests about a week before the expected ablation procedure. The same tests will be repeated 24-48 hours after the ablation. These tests include esophageal manometry, gastric emptying scan, sham feeding test and completing a symptoms questionnaire.

Sponsors & Collaborators

  • Dhanunjaya Lakkireddy, MD, FACC

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · University of Kansas Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396356 on ClinicalTrials.gov