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NCT01396356 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

Completed
Registry status
25
Enrollment target

NCT01396356: Completed study, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

NCT01396356 is a clinical trial that has completed, run by Dhanunjaya Lakkireddy, MD, FACC. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01396356 has completed, sponsored by Dhanunjaya Lakkireddy, MD, FACC.

COMPLETED
Registry status
25 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • PROCEDURE GI procedures

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-08
Est. Completion 2012-12
Dhanunjaya Lakkireddy, MD, FACC

7 total trials

What the finished NCT01396356 record still lists

NCT01396356 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which GI procedures is the first listed.

NCT01396356 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01396356 about?

NCT01396356 is a clinical study titled "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 ...

What is the current status of trial NCT01396356?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2010-08. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01396356?

The interventions under investigation include: GI procedures (PROCEDURE).

Who is sponsoring clinical trial NCT01396356?

This trial is sponsored by Dhanunjaya Lakkireddy, MD, FACC, which has 7 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01396356, the US trial registry maintained by the National Library of Medicine. NCT01396356 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.