MedTrace Logo

Deviating the Esophagus in Atrial Fibrillation Ablation

NCT01546168 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-01-23

Study results available
· View outcomes & findings →

Summary

In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

Conditions

Interventions

DEVICE

esophageal deviation with IDE device

esophageal deviation during AF ablation

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Vivek Reddy

    lead OTHER

Principal Investigators

  • Vivek Reddy, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546168 on ClinicalTrials.gov