Safety and Performance of Electrodes Implanted in the Left Ventricle

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.

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:

• 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.
• 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

• Inability to comply with the study follow-up or other study requirements
• History of chronic alcohol/drug abuse and currently using alcohol/drugs
• Non-ambulatory (or unstable) NYHA class 4
• Contraindication to heparin
• Contraindication to both chronic anticoagulants and antiplatelet agents
• Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
• Thrombocytopenia (platelet count <150,000)
• Contraindication to iodinated contrast agents
• Intracardiac thrombus by transesophageal echocardiography
• Age less than 18 years or greater than 75
• Attempted IPG implant within 3 days
• Life expectancy of less than 12 months
• Chronic hemodialysis
• Stage 4 or 5 renal dysfunction defined as GFR <30
• Grade 4 mitral valve regurgitation
• Myocardial infarction within one month
• Major cardiac surgery within one month
• History of a pericardial effusion in prior procedures
• Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable)
• Non-cardiac implanted electrical stimulation therapy devices