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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Atrial Ablation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 312

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Valley Heart Rhythm Specialists
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension St. Vincent Hospital Indianapolis
  • Michigan
    • Royal Oak, Michigan, United States, 48067
      • Corewell Health Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Washington
    • Tacoma, Washington, United States, 98001
      • MultiCare Institute for Research & Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The sub-study will consist of consecutive male and female patients enrolled in the REAL AF Registry who have symptomatic Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) and undergo left atrial ablation for the treatment of atrial fibrillation.

Description

Inclusion Criteria:

• Symptomatic Paroxysmal Atrial Fibrillation (AF episode terminate spontaneously within 7 days) or Persistent Atrial Fibrillation (AF sustained beyond 7 days) who, in the opinion of the investigator, are scheduled for ablation for Atrial Fibrillation 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 Criteria:

• For the purpose of this sub-study, candidates will be excluded if they meet any of the following criteria:
• Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan.
• In the opinion of the investigator, any known contraindication to an ablation procedure.
• <18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects who undergo left atrial ablation using esophogeal cooling; Study population will consist of consecutive male and female patients in the REAL AF Registry who have symptomatic Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) and undergo left atrial ablation with active esophageal cooling for the treatment of atrial fibrillation.	Device: Atrial Ablation; Left atrial radiofrequency ablation for the treatment of atrial fibrillation; this may include Pulmonary Vein Isolation (PVI) with or without additional ablation lesions as warranted during the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling.	Freedom from atrial arrhythmia recurrence at 90 days post procedure.	90 days
To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling.	Freedom from atrial arrhythmia recurrence at 12 months post procedure	12 months
To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling.	Adverse events from post-procedure through the 12-month office visit date	up to 12-months
Patient reported outcomes in patients treated with active esophageal cooling.	Outcomes reported in modified Gastroesophageal Reflux Disease (GERD) questionnaire. Scale will be scored from "0" (no symptoms) to "3" (maximum symptoms). Higher scores indicate a worse outcome.	7-14 days
Physician reported outcome post procedure with active esophageal cooling.	Assessed using Physician Survey Questionnaire of multiple-choice questions.	Up to 2 months

Collaborators and Investigators

• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
• Collaborators: Attune Medical
• Investigators: Study Chair: Tiffany Sharkoski, MPH, Haemonetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: EVERCOOL AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes