Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392932
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
Esophageal Temperature During PVI Using Q-DOT Micro
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Esophageal Temperature Dynamics and Injury During Pulmonary Vein Isolation With Temperature Controlled Very-High-Power Short-Duration Lesions Using the Novel Q-DOT Micro Ablation Catheter
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study will assess how two different ablation strategies using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation affect the temperature of the esophagus during ablation and the risk of injury to the esophagus
Detailed Description:
This is a prospective randomized controlled trial studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None