Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384599
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-18
Brief Title:
VT Cryoablation System Post-Market Clinical Follow-up PMCF Study
Sponsor:
Adagio Medical
Organization:
Adagio Medical
Study Overview
Official Title:
Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up PMCF Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 PMCF is a prospective single-arm multi-center controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia
Detailed Description:
This VT Post-Market Clinical Follow-up PMCF study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings
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