Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT06561932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Sponsor:
EBR Systems, Inc.
Organization:
Study Overview
Official Title:
A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
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:
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:
False
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?: