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Completed

NCT Number: NCT01396356

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

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.

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Key information

Conditions

Atrial Fibrillation Ablation Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

GI procedures

Procedure

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.

Primary outcomes

  1. 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.

    Time frame: up to 2 weeks

    The esophageal body motility is measured by recording the response to at least 10 wet swallows of 5-10 ml volume.

Secondary outcomes

  1. 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.

    Time frame: up to 2 weeks

    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.

  2. 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.

    Time frame: up to 2 weeks

    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.

  3. To determine if pulmonary vein isolation with radiofrequency ablation impacts the upper gastrointestinal symptoms measured by serial upper GI questionnaire (PAGI-SYM®) scores.

    Time frame: up to 3 months

    The questionnaire has good reproducibility for measuring GI symptoms and validated. The questionnaire will be used at baseline at 3 months after PVI ablation.

Sponsors and collaborators

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2011
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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