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

Completed · Has a placebo group

Conditions studied: Atrial Fibrillation Ablation Procedure

In brief

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.

Key facts

Study ID

NCT01396356

Run by

Dhanunjaya Lakkireddy, MD, FACC

People needed

25

Starts

2010-08-01

Expected to finish

2012-12-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients aged 18 years or more who undergo pulmonary vein isolation with radiofrequency ablation for clinically indicated atrial fibrillation.

You may not qualify if…

• Patients with established diagnosis of esophageal or gastric function abnormalities.
• Patients who are unable to give consent or major psychiatric condition not under control.
• Patients who had abdominal surgical procedures on stomach, esophagus or pancreas (Esophagectomy, Gastrostomy, Gastrectomy (Billroth I, Billroth II, Roux-en-Y), Bariatric surgery [Gastric bypass surgery, Adjustable gastric band, Sleeve gastrectomy, Vertical banded gastroplasty surgery], Gastroenterostomy, Hill repair, Nissen fundoplication, Gastropexy, Pancreatectomy, Pancreaticoduodenectomy, Pancreas transplantation, vagotomy).
• Patients who unable to undergo any of the above mentioned procedures namely, esophageal manometry or sham feeding test or scientigraphy gastric emptying scan.
• Patients with chronic pancreatitis.
• Patients with either acute or chronic neuropathies such as diabetic, inflammatory, autoimmune and cranial neuropathies effecting vagal nerve or gastroparesis or achalasia. Limited peripheral neuropathies such as carpal tunnel syndrome or isolated Bell's palsy can be included.
• Patients who have undergone previous radiofrequency ablation for atrial fibrillation or patients who had history of either minimally invasive or invasive or maze or modified maze procedures for atrial fibrillation.

Where it is running

• The University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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