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Esophageal Cooling in Radiofrequency Cardiac Ablation

NCT03481023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-02-28

Study results available
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Summary

This pilot study evaluates the addition of the EnsoETM esophageal cooling device to the radiofrequency (RF) ablation procedure in the treatment of atrial fibrillation in adults. Half of participants will receive the EnsoETM in addition to RF ablation, while the other half will receive luminal esophageal temperature (LET) monitoring during RF ablation.

Conditions

Interventions

DEVICE

EnsoETM

Use of esophageal thermal regulation device during radiofrequency ablation.

PROCEDURE

Conventional Care

Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.

Sponsors & Collaborators

  • Attune Medical

    collaborator OTHER

  • Riverside Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2018-11-20
Completion
2018-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03481023 on ClinicalTrials.gov