Heart Failure Clinical Trial
— SELECT-LVOfficial title:
Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Verified date | February 2018 |
Source | EBR Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 2019 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Na Homolce Hospital | Prague | |
Denmark | Aalborg University Hospital | Aalborg |
Lead Sponsor | Collaborator |
---|---|
EBR Systems, Inc. |
Czechia, Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 hour peri-operative and one month | |
Primary | 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. | 24 hour perioperative and one month | |
Primary | Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | one month | |
Secondary | 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. | 6 months | |
Secondary | Number of patients with serious adverse events as a measure of safety | 6 months | ||
Secondary | Bi-ventricular pacing capture | Bi-ventricular pacing capture documented on 12-lead EKG | 6 months | |
Secondary | Clinical composite score | Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment | 6 months | |
Secondary | Change in echocardiographic indices | change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction | 6 months |
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