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

Atrial Fibrillation Clinical Trial

— EVERCOOL AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354777
• Other study ID #: EVERCOOL AF
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Heart Rhythm Clinical and Research Solutions, LLC
• Contact: Carla Perna
• Phone: 205-223-0960
• Email: cperna[@]hrcrs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablation Procedure
Left atrial radiofrequency ablation for the treatment of atrial fibrillation. This may include pulmonary vein isolation with or without additional ablation lesions as warranted during the procedure.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Heart Rhythm Clinical and Research Solutions, LLC	Attune Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physician reported outcome post procedure with active esophageal cooling.	Assessed using Physician Survey Questionnaire of multiple-choice questions.	Up to 2 months