Examining the effects of active esophageal cooling during atrial fibrillation ablation
REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-study of the REAL AF Registry
This study is testing if using active cooling on the esophagus during heart ablation can help people with atrial fibrillation have safer and more effective procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 312 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heart Rhythm Clinical and Research Solutions, LLC Academic / other |
| Locations | 5 sites (Chandler, Arizona and 4 other locations) |
| Trial ID | NCT06354777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptomatic Paroxysmal or Persistent Atrial Fibrillation scheduled for ablation.
Not a fit: Patients under 18 or those with contraindications to ablation procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective atrial fibrillation ablation procedures with fewer complications.
How similar studies have performed: Previous studies, including the IMPACT trial, have shown promising results with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chandler, Arizona and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.