Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT01396356
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2011-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
Sponsor:
Dhanunjaya Lakkireddy, MD, FACC
Organization:
Study Overview
Official Title:
Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
This study is designed to determine how often atrial fibrillation ablation causes problems with the stomach and esophagus.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: