Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495216
Status:
WITHDRAWN
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation PFA by Balloon Catheter With TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation PAF
Sponsor:
Biosense Webster Inc
Organization:
Biosense Webster Inc
Study Overview
Official Title:
Exploratory Safety and Effectiveness Evaluation of Pulsed Field Ablation by a Balloon Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation PAF
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision no sites were activated nor were any patients enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZephIRE
Brief Summary:
The purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system pulsed field ablation balloon catheter and TRUPULSE generator when used for isolation of the atrial pulmonary veins PVs in treatment of participants with paroxysmal atrial fibrillation PAF an irregular heart rate that causes abnormal blood flow
Detailed Description:
None
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