REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry

Last updated: October 29, 2025
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Dysrhythmia

Atrial Fibrillation

Treatment

Ablation Procedure

Atrial Ablation

Clinical Study ID

NCT06354777
EVERCOOL AF
  • Ages > 18
  • All Genders

Study Summary

This is a multi-center sub-study examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic Paroxysmal Atrial Fibrillation (AF episode terminate spontaneouslywithin 7 days) or Persistent Atrial Fibrillation (AF sustained beyond 7 days) who,in the opinion of the investigator, are scheduled for ablation for AtrialFibrillation with active esophageal cooling.

  • >18 years of age

  • Index or redo ablation procedure and enrolled in the REAL AF Registry

  • Willing and able to provide informed consent and complete GERD questionnaire.

Exclusion

Exclusion Criteria:

  • For the purpose of this sub-study, candidates will be excluded if they meet any ofthe following criteria:

  • Enrolled in an investigational drug or device clinical trial, or any trial thatdictates the treatment plan.

  • In the opinion of the investigator, any known contraindication to an ablationprocedure.

  • <18 years of age

Study Design

Total Participants: 312
Treatment Group(s): 2
Primary Treatment: Ablation Procedure
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
December 30, 2026

Study Description

Treatment of atrial fibrillation, using pulmonary vein isolation, involves some risks to collateral structure, including the esophagus. Active esophageal cooling has shown benefits in multiple studies when used in the treatment of Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation during left atrial ablation. The largest randomized, controlled trial to date, the IMPACT study, found an 83% reduction in endoscopically identified esophageal lesions when using the active cooling, with a dedicated device, compared to standard esophageal monitoring, with no difference in Atrial Fibrillation recurrence rates at follow-up. Recent analyses have suggested additional effects from active esophageal cooling during pulmonary vein isolation, including reductions in procedure time, reductions in fluoroscopy usage, reductions in post-ablation discomfort, and improvements in long-term freedom from arrhythmia. Further investigation of these associations is important to better understand the magnitude of these findings in a variety of clinical settings.

Connect with a study center

  • Valley Heart Rhythm Specialists

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Valley Heart Rhythm Specialists

    Chandler 5289282, Arizona 5551752 85224
    United States

    Site Not Available

  • Ascension St. Vincent Hospital Indianapolis

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Ascension St. Vincent Hospital Indianapolis

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Site Not Available

  • Corewell Health Research Institute

    Royal Oak, Michigan 48067
    United States

    Site Not Available

  • Corewell Health Research Institute

    Royal Oak 5007804, Michigan 5001836 48067
    United States

    Site Not Available

  • Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington 98001
    United States

    Site Not Available

  • MultiCare Institute for Research & Innovation

    Tacoma 5812944, Washington 5815135 98001
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.