Safety and Performance of Electrodes Implanted in the Left Ventricle

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: WiCS-LV system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant<br>Implant of the WiCS-LV system | Device: WiCS-LV system<br>* 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<br>* Other names: Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with device-related adverse events as a measure of safety | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. | 24 hour peri-operative and one month | 
| Number of patients with procedure-related adverse events as a measure of safety | Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure. | 24 hour perioperative and one month | 
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with device-related adverse events as a measure of safety | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. | 6 months | 
| Number of patients with serious adverse events as a measure of safety |  | 6 months | 
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | 6 months | 
| Clinical composite score | Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment | 6 months | 
| Change in echocardiographic indices | change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing