Multicenter, prospective evaluation of performance, safety, and surveillance of the WiCS-LV System in patients indicated for Cardiac Resynchronization Therapy - Wireless Stimulation Endocardially for CRT

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5月6日

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•In this study, patients providing informed consent will be enrolled responding to the following criteria:;Patients with standard indications for CRT based upon the most recent ESC/EHRA 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*;Previously implanted or newly implanted CRT*s, pacemakers and ICD devices must provides dual-chamber pacing (RA and RV) if the patient has sinus rhythm, single-chamber pacing (RV) if the patient is in permanent AF

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

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