Safety and Performance of Electrodes implanted in the LV

Completed

• Conditions: Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy; 10019280

• Registration Number: NL-OMON40357
• Lead Sponsor: EBR Systems Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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*
Investigator

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified