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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
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
Na Homolce Hospital
Prague, Czechia
Aalborg University Hospital
Aalborg, Denmark
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.
Time frame: 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.
Time frame: 24 hour perioperative and one month
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Time frame: one month
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.
Time frame: 6 months
Number of patients with serious adverse events as a measure of safety
Time frame: 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Time frame: 6 months
Clinical composite score
Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
Time frame: 6 months
Change in echocardiographic indices
change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
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Time frame: 6 months