NCT01905670

Safety and Performance of Electrodes Implanted in the Left Ventricle

Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: EBR Systems, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is intended to demonstrate the safe implant of small receiver-electrodes into the endocardial surface of the left ventricle and to demonstrate its utility in providing cardiac resynchronization therapy in heart failure patients.

Detailed description

Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system. Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.

Conditions

• Heart Failure
• Ventricular Dysfunction
• Cardiomyopathies
• Heart Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	WiCS-LV system	Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-08-01
• Completion: 2019-11-01
• First posted: 2013-07-23
• Last updated: 2020-07-09

Locations

2 sites across 2 countries: Czechia, Denmark