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Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation

NCT03645070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-10

No results posted yet for this study

Summary

It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring.

These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer.

The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.

Conditions

Interventions

DEVICE

multipolar and self expandable thermometer

Will be evaluated if a multipolar and self expandable thermometer is superior to no probe or to single probe thermometer at prevention of esophageal thermal injury.

DEVICE

Single probe thermometer

Will be evaluated if a single probe thermometer is superior to a multipolar and self expandable thermometer or to no probe thermometer at prevention of esophageal thermal injury

Sponsors & Collaborators

  • Circa Scientific, Inc.

    collaborator INDUSTRY

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Mauricio I Scanavacca, MD, PhD · Instituto do coração - HC/FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2018-10-01
Completion
2020-07-24
FDA Device
Yes

Countries

  • Brazil

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 NCT03645070 on ClinicalTrials.gov