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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01396356
First received: June 20, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation Ablation Procedure
Procedure: GI procedures

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The esophageal body motility is measured by recording the response to at least 10 wet swallows of 5-10 ml volume.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The questionnaire has good reproducibility for measuring GI symptoms and validated. The questionnaire will be used at baseline at 3 months after PVI ablation.


Estimated Enrollment: 25
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ablation procedure 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion criteria:

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

Exclusion criteria:

  1. Patients with established diagnosis of esophageal or gastric function abnormalities.
  2. Patients who are unable to give consent or major psychiatric condition not under control.
  3. 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).
  4. Patients who unable to undergo any of the above mentioned procedures namely, esophageal manometry or sham feeding test or scientigraphy gastric emptying scan.
  5. Patients with chronic pancreatitis.
  6. 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.
  7. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396356

Locations
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01396356     History of Changes
Other Study ID Numbers: 12164
Study First Received: June 20, 2011
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014