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Esophageal Temperature Management During Cryo AF Ablation (EnsoETM)

NCT04079634 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-05-16

Study results available
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Summary

The purpose of this pilot study is to determine if esophageal warming using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) limits the frequency or severity of thermal injury during cryoballoon ablation of atrial fibrillation.

Conditions

Interventions

DEVICE

Esophageal warming

Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure

DEVICE

Control

Standard temperature probe monitoring

Sponsors & Collaborators

Principal Investigators

  • Nishant Verma, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2021-09-30
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04079634 on ClinicalTrials.gov