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NCT Number: NCT06354777

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Valley Heart Rhythm Specialists, Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrial Ablation

Device

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

Primary outcomes

  1. To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling.

    Time frame: 90 days

    Freedom from atrial arrhythmia recurrence at 90 days post procedure.

  2. To measure procedural efficacy after atrial fibrillation ablation in patients treated with active esophageal cooling.

    Time frame: 12 months

    Freedom from atrial arrhythmia recurrence at 12 months post procedure

  3. To measure long term safety after atrial fibrillation in patients treated with active esophageal cooling.

    Time frame: up to 12-months

    Adverse events from post-procedure through the 12-month office visit date

  4. Patient reported outcomes in patients treated with active esophageal cooling.

    Time frame: 7-14 days

    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.

  5. Physician reported outcome post procedure with active esophageal cooling.

    Time frame: Up to 2 months

    Assessed using Physician Survey Questionnaire of multiple-choice questions.

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Attune Medical

Registry information

Acronym: EVERCOOL AF

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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