Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-02-28
Brief Title:
REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing A Sub-Study of the REAL AF Registry
Sponsor:
Heart Rhythm Clinical and Research Solutions LLC
Organization:
Heart Rhythm Clinical and Research Solutions LLC
Study Overview
Official Title:
REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing A Sub-study of the REAL AF Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVERCOOL AF
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None