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Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY

NCT04659213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-10-31

No results posted yet for this study

Summary

To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

Conditions

Interventions

DEVICE

esolution catheter

esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury

Sponsors & Collaborators

  • S4 Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-06-30
Completion
2022-07-31
FDA Device
Yes

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 NCT04659213 on ClinicalTrials.gov