Atrial Fibrillation Ablation on Gastric Motility - Full Text View

Sponsor:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT01396356

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Esophagus Disorders

U.S. FDA Resources

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
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (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:

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.

Contacts and Locations

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

Contacts

Contact: Caroline Murray, CCRP

913-588-9679

cmurray@mac.md

Locations

United States, Kansas
The University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Caroline Murray, CCRP 913-588-9679 cmurray@mac.mc
Principal Investigator: Dhanunjaya Lakkireddy, MD

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Dhanunjaya Lakkireddy, MD

The University of Kansas Medical Center

More Information

No publications provided

Responsible Party:	Dhanunjaya Lakkireddy, MD, The University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT01396356 History of Changes
Other Study ID Numbers:	12164
Study First Received:	June 20, 2011
Last Updated:	July 14, 2011
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 May 23, 2012