Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578104
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
PULSED AF Post-Approval Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PULSED AF Post-Approval Study an Addendum to the PulseSelect PFA Global Registry
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
PULSED AF PAS is a prospective global multi-center non-randomized observational trial Subjects will be treated with the PulseSelect PFA System and followed through 36 months
Detailed Description:
PulseSelect is a prospective global multi-center non-randomized observational trial Subjects will be treated with the PulseSelect PFA System and followed through 36 months Study visits will occur at 3 6 12 24 and 36 months post-ablation including required 24-hour Holter monitoring at 6 12 24 and 36 month visits The PulseSelect PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care
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