Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- EBR Systems, Inc.
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Number of patients with device-related adverse events as a measure of safety
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Implant
Implant of the WiCS-LV system
Intervention: WiCS-LV system (Device)
Outcomes
Primary Outcomes
Number of patients with device-related adverse events as a measure of safety
Time Frame: 24 hour peri-operative and one month
Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
Bi-ventricular pacing capture
Time Frame: one month
Bi-ventricular pacing capture documented on 12-lead EKG
Number of patients with procedure-related adverse events as a measure of safety
Time Frame: 24 hour perioperative and one month
Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
Secondary Outcomes
- Number of patients with device-related adverse events as a measure of safety(6 months)
- Number of patients with serious adverse events as a measure of safety(6 months)
- Change in echocardiographic indices(6 months)
- Bi-ventricular pacing capture(6 months)
- Clinical composite score(6 months)