NCT01396356|Completed
Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
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Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
Sponsor study identifier
observational
25
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 20, 2011
Actual (reported)July 18, 2011
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)To determine if pulmonary vein isolation with radiofrequency ablation impacts the upper gastrointestinal function by evaluating the Gastric and esophageal motility the lower esophageal sphincter tone changes by esophageal manometry.
The esophageal body motility is measured by recording the response to at least 10 wet swallows of 5-10 ml volume.
up to 2 weeks
To determine if pulmonary vein isolation with radiofrequency ablation impacts the upper gastrointestinal function by evaluating the Gastric and esophageal motility gastric emptying time measured by a scintigraphy gastric emptying scan.
up to 2 weeks
To determine if pulmonary vein isolation with radiofrequency ablation impacts the upper gastrointestinal function by evaluating the Gastric and esophageal motility through the vagal nerve function by sham feeding test.
up to 2 weeks
To determine if pulmonary vein isolation with radiofrequency ablation impacts the upper gastrointestinal symptoms measured by serial upper GI questionnaire (PAGI-SYM®) scores.
up to 3 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Lakkireddy D, Reddy YM, Atkins D, Rajasingh J, Kanmanthareddy A, Olyaee M, Dusing R, Pimentel R, Bommana S, Dawn B. Effect of atrial fibrillation ablation on gastric motility: the atrial fibrillation gut study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):531-6. doi: 10.1161/CIRCEP.114.002508. Epub 2015 Mar 14.
Dhanunjaya Lakkireddy, MD
University of Kansas Medical Center
First Submitted
June 20, 2011
First Posted
July 18, 2011
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Contact the study team to confirm eligibility.
Study Completion
December 2012
Actual (reported)Last Updated
January 10, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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