COMPANY

EBR Systems

Profile checked Oct 10, 2026

Keywords: Heart Failure Ventricular Dysfunction Cardiac Resynchronization Therapy Cardiomyopathies Heart Diseases Cardiovascular Diseases Cardiomyopathy WiCS-LV System The Wise System WiSE CRT System WiSE System Wireless cardiac stimulator implant to pace the left ventricle for CRT

6Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Dec 18, 2025 Trial start Not phased (device or behavioral study): A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT source ↗
Nov 3, 2025 Trial start —: The WiSE®-UP Study (The WiSE System Utilization & Performance Study) source ↗
Apr 11, 2025 FDA FDA PMA approval: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System — P240028, Apr 11, 2025. Applicant at approval: EBR Systems, Inc. source ↗
Jan 17, 2018 Trial start Not phased (device or behavioral study): Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients source ↗
Feb 8, 2016 Trial start —: WiCS-LV Post Market Surveillance Registry source ↗
2013-07 Trial start Not phased (device or behavioral study): Safety and Performance of Electrodes Implanted in the Left Ventricle source ↗
2011-02 Trial start Not phased (device or behavioral study): Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy source ↗

Upcoming milestones

Apr 1, 2027 (ESTIMATED) · Not phased · A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT · NCT06561932
2027-06 (ESTIMATED) · · WiCS-LV Post Market Surveillance Registry · NCT02610673
Sep 30, 2032 (ESTIMATED) · · The WiSE®-UP Study (The WiSE System Utilization & Performance Study) · NCT07098858

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 6

Record	Title	Phase	Status	Start	Primary completion
NCT07098858	The WiSE®-UP Study (The WiSE System Utilization & Performance Study)	Not listed	Recruiting	Nov 3, 2025	Sep 30, 2032 (estimated)
NCT06561932	A Feasibility Study Implant of the WiSE® CRT System With an Intracardiac Pacemaker to Achieve Totally Leadless CRT	Not phased (device or behavioral study)	Recruiting	Dec 18, 2025	Apr 1, 2027 (estimated)
NCT02922036	Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients	Not phased (device or behavioral study)	Active, not recruiting	Jan 17, 2018	2026-06 (estimated)
NCT02610673	WiCS-LV Post Market Surveillance Registry	Not listed	Active, not recruiting	Feb 8, 2016	2027-06 (estimated)
NCT01905670	Safety and Performance of Electrodes Implanted in the Left Ventricle	Not phased (device or behavioral study)	Completed	2013-07	2015-08 (actual)
NCT01294527	Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy	Not phased (device or behavioral study)	Completed	2011-02	2012-04 (actual)

FDA records (last 2 years)

Apr 11, 2025 FDA PMA approval: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System — P240028, Apr 11, 2025. Applicant at approval: EBR Systems, Inc. source ↗

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