NCT01294527

Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: EBR Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

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
• Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	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: 2011-02-01
• Primary completion: 2012-04-01
• Completion: 2016-10-01
• First posted: 2011-02-11
• Last updated: 2017-02-08

Locations

10 sites across 4 countries: France, Germany, Netherlands, Switzerland