Safety and Performance of Electrodes Implanted in the Left Ventricle

Heart Failure Clinical Trial

— SELECT-LV  

Official title:

Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

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
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Ventricular Dysfunction

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