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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01905670
Other study ID # EBR-02494
Secondary ID CIV-13-04-010803
Status Completed
Phase N/A
First received
Last updated
Start date July 2013
Est. completion date November 2019

Study information

Verified date February 2018
Source EBR Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
WiCS-LV system
Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator

Locations

Country Name City State
Czechia Na Homolce Hospital Prague
Denmark Aalborg University Hospital Aalborg

Sponsors (1)

Lead Sponsor Collaborator
EBR Systems, Inc.

Countries where clinical trial is conducted

Czechia,  Denmark, 

Outcome

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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