Cardiomyopathies, Cardiovascular Diseases, Heart Diseases, Heart Failure, Ventricular Dysfunction
Conditions
Keywords
Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
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.
Interventions
DEVICEWiCS-LV system
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
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 75 Years
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: 1. 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. 2. 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
1. Inability to comply with the study follow-up or other study requirements 2. History of chronic alcohol/drug abuse and currently using alcohol/drugs 3. Non-ambulatory (or unstable) NYHA class 4 4. Contraindication to heparin 5. Contraindication to both chronic anticoagulants and antiplatelet agents 6. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents) 7. Thrombocytopenia (platelet count \<150,000) 8. Contraindication to iodinated contrast agents 9. Intracardiac thrombus by transesophageal echocardiography 10. Age less than 18 years or greater than 75 11. Attempted IPG implant within 3 days 12. Life expectancy of less than 12 months 13. Chronic hemodialysis 14. Stage 4 or 5 renal dysfunction defined as GFR \<30 15. Grade 4 mitral valve regurgitation 16. Myocardial infarction within one month 17. Major cardiac surgery within one month 18. History of a pericardial effusion in prior procedures 19. Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable) 20. Non-cardiac 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 |
|---|---|---|
| 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 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 | — |
| Bi-ventricular pacing capture | 6 months | Bi-ventricular pacing capture documented on 12-lead EKG |
Countries
Czechia, Denmark
Outcome results
None listed