Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510556
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Feasibility Study of the MAVERICK Mapping and PFA System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Study of the MAVERICK Mapping and Pulsed Field Ablation PFA System in the Treatment of Persistent Atrial Fibrillation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEVATE-PF
Brief Summary:
The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation PFA catheter a novel catheter in treating persistent atrial fibrillation PersAF
Detailed Description:
The objective of this study is to obtain First-in-Human FIH experience with the FARFLEX PFA mapping and ablation PFA catheter in the treatment of persistent Atrial Fibrillation persAF
Subjects with symptomatic Persistent Atrial Fibrillation will be included in this study
Subjects with symptomatic Persistent Atrial Fibrillation will be included in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None