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Procedure

esolution catheter for Atrial Fibrillation

N/A
Waitlist Available
Research Sponsored by S4 Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-72 hours post-ablation procedure
Awards & highlights

Study Summary

This study is evaluating whether deviating the esophagus will reduce/eliminate ablation injury to the esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-72 hours post-ablation procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15-72 hours post-ablation procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interventional GroupExperimental Treatment1 Intervention
Placement of a luminal esophageal temperature probe (LET) and insertion of esolution esophageal retractor. In the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation
Group II: Control GroupActive Control1 Intervention
Placement of a luminal esophageal temperature probe (LET) during RF ablation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
esolution catheter
2021
N/A
~130

Find a Location

Who is running the clinical trial?

S4 MedicalLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
2021. "Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04659213.
~36 spots leftby Apr 2025
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