Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

Study Overview
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Brief Summary
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The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

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 Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

Conditions
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Heart Failure, Ventricular Dysfunction, Cardiomyopathy

Intervention / Treatment
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* Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Wireless cardiac stimulator implant to pace the left ventricle for CRT<br>* Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator<br>* Other names: WiCS-LV system;|

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 | 
| Left ventricular pacing capture | Left ventricular pacing capture documented on 12-lead EKG | 1, 3, and 6 months | 
| Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | 3 and 6 months | 
| Bi-ventricular pacing capture | Bi-ventricular pacing capture on 24 hour ambulatory monitoring | 1, 3, and 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 | 
| Change in blood laboratory Brain Natriuretic Peptide | change in NT-proBNP level | 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