Safety and Performance of Electrodes Implanted in the Left Ventricle
NCT01905670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2020-07-09
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.
Conditions
- Heart Failure
- Ventricular Dysfunction
- Cardiomyopathies
- Heart Diseases
- Cardiovascular Diseases
Interventions
- 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
Sponsors & Collaborators
-
EBR Systems, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2015-08-31
- Completion
- 2019-11-30
Countries
- Czechia
- Denmark
Study Locations
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