Examining the effects of active esophageal cooling during atrial fibrillation ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational sub-study investigates the effectiveness of active esophageal cooling in patients undergoing left atrial ablation for symptomatic Paroxysmal or Persistent Atrial Fibrillation. The study aims to assess the impact of this cooling technique on reducing risks to the esophagus and improving overall procedural outcomes. By analyzing data from multiple centers, the research seeks to clarify the benefits of active cooling, including potential reductions in procedure time and post-ablation discomfort, while ensuring patient safety. Participants will be enrolled from the REAL AF Registry and will undergo a thorough evaluation to determine eligibility.

Why it matters

Who can join: the full rules

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

Where it's running

• Valley Heart Rhythm Specialists
  Chandler, Arizona, United States Recruiting
• Ascension St. Vincent Hospital Indianapolis
  Indianapolis, Indiana, United States Recruiting
• Christ Hospital
  Cincinnati, Ohio, United States Recruiting
• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting
• MultiCare Institute for Research & Innovation
  Tacoma, Washington, United States Recruiting

Study contacts

• Study coordinator: Carla Perna
• Email: cperna@hrcrs.com
• Phone: 205-223-0960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.