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.
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
17
Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
Nouvelles Clinicques Nantaises
Nantes, France
Hospital Pontchaillou-CHU
Rennes, France
Kerckhoff-Klinik
Bad Nauheim, Germany
Herzzentrum Brandenburg
Bernau, Germany
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
Left ventricular pacing capture
Left ventricular pacing capture documented on 12-lead EKG
Time frame: 1, 3, and 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Time frame: 3 and 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture on 24 hour ambulatory monitoring
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinium Coburg gGmbH
Coburg, Germany
Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Leiden University Medical Centre
Leiden, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
Cardiocentro Ticini
Lugano, Switzerland
Time frame: 1, 3, and 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
Time frame: 6 months
Change in blood laboratory Brain Natriuretic Peptide
change in NT-proBNP level
Time frame: 6 months