Cardiomyopathy, Heart Failure, Ventricular Dysfunction
Conditions
Keywords
Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
Brief summary
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
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.
Interventions
DEVICEWireless cardiac stimulator implant to pace the left ventricle for CRT
Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
Sponsors
EBR Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories: 1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as upgrades 2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as untreated 3. 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
1. Inability to comply with the study follow-up or other study requirements 2. Contraindication to heparin 3. Contraindication to both chronic anticoagulants and antiplatelet agents 4. Contraindication to iodinated contrast agents 5. Intracardiac thrombus by transesophageal echocardiography 6. Age less than 18 years 7. Attempted IPG implant within 3 days 8. Life expectancy of \< 12 months 9. Chronic hemodialysis 10. Myocardial infarction within one month 11. Major cardiac surgery within one month 12. Female of childbearing potential, pregnant, or breastfeeding 13. Noncardiac implanted electrical stimulation therapy devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with device-related adverse events as a measure of safety | 24 hour peri-operative and one month | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. |
| Number of patients with procedure-related adverse events as a measure of safety | 24 hour perioperative and one month | Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure. |
| Bi-ventricular pacing capture | one month | Bi-ventricular pacing capture documented on 12-lead EKG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bi-ventricular pacing capture | 3 and 6 months | Bi-ventricular pacing capture documented on 12-lead EKG |
| Clinical composite score | 6 months | Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment |
| Number of patients with device-related adverse events as a measure of safety | 6 months | Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible. |
| Change in blood laboratory Brain Natriuretic Peptide | 6 months | change in NT-proBNP level |
| Change in echocardiographic indices | 6 months | change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction |
| Number of patients with serious adverse events as a measure of safety | 6 months | — |
| Left ventricular pacing capture | 1, 3, and 6 months | Left ventricular pacing capture documented on 12-lead EKG |
Countries
France, Germany, Netherlands, Switzerland
Outcome results
None listed