Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355063
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-01
Brief Title:
CellFX nsPFA Cardiac Surgery System to Treat Atrial Fibrillation
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
Official Title:
Initial Safety and Performance of the CellFX nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-09
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 feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX nsPFA Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure
Detailed Description:
This study is a prospective multicenter single arm non-randomized feasibility study Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein roof and floor ablations to form a left atrial posterior box All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
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