Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393920
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-28
Brief Title:
PulseSelect PFA Global Registry
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
PulseSelect PFA Global Registry a Part of the Medtronic Cardiac Ablation Post-Market Study Platform
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The PulseSelect PFA Global Registry is a prospective global multi-center observational post-approval study Subjects will be treated with the PulseSelect PFA System and followed according to SOC
Detailed Description:
The PulseSelect PFA Global Registry is a prospective global multi-center observational post-market registry The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect PFA system The PulseSelect PFA System used in the study is market approved The ablation procedure will be performed according to routine hospital practice The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure
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