Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT03437733
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Sponsor:
Biosense Webster, Inc.
Organization:
Study Overview
Official Title:
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Status:
COMPLETED
Status Verified Date:
2025-06
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:
SHINE
Brief Summary:
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
Detailed Description:
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: