Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711589
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2023-01-18
Brief Title:
Zero-fluoroscopic Cryoballoon Ablation
Sponsor:
Pusan National University Hospital
Organization:
Pusan National University Hospital
Study Overview
Official Title:
Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-02
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 aimed to investigate safety and efficacy of intracardiac echocardiography ICE-guided zero-fluoroscopic cryoballoon ablation CBA in patients with paroxysmal atrial fibrillation
Detailed Description:
Patients n100 undergoing de novo CBA for paroxysmal AF were randomly assigned 11 to zero-fluoroscopic Zero-X and conventional fluoroscopy groups
Radiation exposure procedural time acute and long term outcome were analyzed
Radiation exposure procedural time acute and long term outcome were analyzed
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