Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

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 indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:

• Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
• Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
• Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"

Exclusion criteria

• Inability to comply with the study follow-up or other study requirements
• Contraindication to heparin
• Contraindication to both chronic anticoagulants and antiplatelet agents
• Contraindication to iodinated contrast agents
• Intracardiac thrombus by transesophageal echocardiography
• Age less than 18 years
• Attempted IPG implant within 3 days
• Life expectancy of < 12 months
• Chronic hemodialysis
• Myocardial infarction within one month
• Major cardiac surgery within one month
• Female of childbearing potential, pregnant, or breastfeeding
• Noncardiac implanted electrical stimulation therapy devices