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

NCT06354777 | Active Not Recruiting FDA Device

• 1 other identifier: EVERCOOL AF
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

Interventions

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

Subjects who undergo left atrial ablation using esophogeal cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart Rhythm Clinical and Research Solutions, LLC: lead
• Attune Medical: collaborator

Study Sites (6)

Valley Heart Rhythm Specialists

Chandler, Arizona, 85224, United States

Location

Ascension St. Vincent Hospital Indianapolis

Indianapolis, Indiana, 46260, United States

Location

Corewell Health Research Institute

Royal Oak, Michigan, 48067, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98001, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Tiffany Sharkoski, MPH

  Haemonetics Corporation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 9, 2024
• Study Start: April 3, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)