Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561932
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Feasibility Study Implant of the WiSE CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Feasibility Study Into the Implant of the WiSE CRT System With an Intracardiac
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:
TLC-AU
Brief Summary:
Assess the safety and efficacy of the co-implantation of the WiSE CRT System with an intracardiac pacemaker to provide totally leadless CRT
Detailed Description:
The WiSE CRT System is an implantable cardiac system to provide left ventricular LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular RV stimulation In combination the devices deliver biventricular BiV pacing
Single-arm prospective multicenter observational study
Single-arm prospective multicenter observational 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