REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry
NCT06354777 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 312
Last updated 2025-10-31
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
Interventions
- DEVICE
-
Atrial Ablation
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
Sponsors & Collaborators
-
Attune Medical
collaborator OTHER -
Heart Rhythm Clinical and Research Solutions, LLC
lead OTHER
Principal Investigators
-
Tiffany Sharkoski, MPH · Haemonetics Corporation
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-03
- Primary Completion
- 2026-04-30
- Completion
- 2026-12-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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