Safety and Performance of Electrodes implanted in the LV - SELECT-LV

EBR Systems Inc.0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

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•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*
•Investigator

•Study patients responding to the following criteria are excluded from enrollment:
•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

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