Safety and Performance of Electrodes Implanted in the Left Ventricle

Not Applicable

Completed

• Conditions: Cardiomyopathies; Heart Failure; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

• Registration Number: NCT01905670
• Lead Sponsor: EBR Systems, Inc.

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-23
• Primary Completion: 2015-08
• Status Verified: 2018-02
• Study Completion: 2019-11
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
Bi-ventricular pacing capture	one month	Bi-ventricular pacing capture documented on 12-lead EKG
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.

Secondary Outcome Measures

Name	Time	Method
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.
Number of patients with serious adverse events as a measure of safety	6 months
Change in echocardiographic indices	6 months	change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
Bi-ventricular pacing capture	6 months	Bi-ventricular pacing capture documented on 12-lead EKG
Clinical composite score	6 months	Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment

Trial Locations

Locations (2)

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark