Safety and Performance of Electrodes Implanted in the Left Ventricle

NCT ID: NCT01905670

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-11-30

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.

Conditions

Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implant

Implant of the WiCS-LV system

Group Type: EXPERIMENTAL

WiCS-LV system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Implant

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EBR Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Na Homolce Hospital

Prague, , Czechia

Aalborg University Hospital

Aalborg, , Denmark

Countries

Czechia; Denmark

References

Reddy VY, Miller MA, Neuzil P, Sogaard P, Butter C, Seifert M, Delnoy PP, van Erven L, Schalji M, Boersma LVA, Riahi S. Cardiac Resynchronization Therapy With Wireless Left Ventricular Endocardial Pacing: The SELECT-LV Study. J Am Coll Cardiol. 2017 May 2;69(17):2119-2129. doi: 10.1016/j.jacc.2017.02.059.

Reference Type: DERIVED

PMID: 28449772 (View on PubMed)

Other Identifiers

CIV-13-04-010803

Identifier Type: OTHER

Identifier Source: secondary_id

EBR-02494

Identifier Type: -

Identifier Source: org_study_id