An observational study in Atrial Fibrillation Ablation Procedure, sponsored by Dhanunjaya Lakkireddy, MD, FACC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Dhanunjaya Lakkireddy, MD, FACC · Observational
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 25 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Dhanunjaya Lakkireddy, MD, FACC is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion criteria:
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.
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.
Time frame: 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.
Anterior and posterior scintigraphic images of the stomach will be obtained within 1 minute of completion of the meal (defined as 0) and at 60, 120, 180, and 240 minutes.
Time frame: 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.
Blood samples of glucose and pancreatic polypeptide will be collected at 10-minute intervals for 30 minutes after the initiation of the meal. If the elevation over baseline value of pancreatic polypeptide after the sham meal is \<50%, then this is considered as a positive test, indicating that vagal nerve damage or essentially that a "vagotomy" had occurred.
Time frame: 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.
The questionnaire has good reproducibility for measuring GI symptoms and validated. The questionnaire will be used at baseline at 3 months after PVI ablation.
Time frame: up to 3 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Dhanunjaya Lakkireddy, MD, FACC