This trial is active, not recruiting.

Conditions heart failure, ventricular dysfunction, cardiomyopathies, heart diseases, cardiovascular diseases
Treatment wics-lv system
Sponsor EBR Systems, Inc.
Start date July 2013
End date August 2015
Trial size 39 participants
Trial identifier NCT01905670, CIV-13-04-010803, EBR-02494


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Implant of the WiCS-LV system
wics-lv system Implant
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

Primary Outcomes

Number of patients with device-related adverse events as a measure of safety
time frame: 24 hour peri-operative and one month
Number of patients with procedure-related adverse events as a measure of safety
time frame: 24 hour perioperative and one month
Bi-ventricular pacing capture
time frame: one month

Secondary Outcomes

Number of patients with device-related adverse events as a measure of safety
time frame: 6 months
Number of patients with serious adverse events as a measure of safety
time frame: 6 months
Bi-ventricular pacing capture
time frame: 6 months
Clinical composite score
time frame: 6 months
Change in echocardiographic indices
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these two categories: 1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as "upgrades". Justifications for not using standard CRT must be documented in a CRF. 2. Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as "untreated" Exclusion Criteria: 1. Inability to comply with the study follow-up or other study requirements 2. History of chronic alcohol/drug abuse and currently using alcohol/drugs 3. Non-ambulatory (or unstable) NYHA class 4 4. Contraindication to heparin 5. Contraindication to both chronic anticoagulants and antiplatelet agents 6. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents) 7. Thrombocytopenia (platelet count <150,000) 8. Contraindication to iodinated contrast agents 9. Intracardiac thrombus by transesophageal echocardiography 10. Age less than 18 years or greater than 75 11. Attempted IPG implant within 3 days 12. Life expectancy of less than 12 months 13. Chronic hemodialysis 14. Stage 4 or 5 renal dysfunction defined as GFR <30 15. Grade 4 mitral valve regurgitation 16. Myocardial infarction within one month 17. Major cardiac surgery within one month 18. History of a pericardial effusion in prior procedures 19. Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable) 20. Non-cardiac implanted electrical stimulation therapy devices

Additional Information

Official title Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by EBR Systems, Inc..