Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Failure; Cardiomyopathies; Ventricular Dysfunction
• Intervention / Treatment: Device: WiCS-LV system

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Implant; Implant of the WiCS-LV system	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; Other Names: Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Bi-ventricular pacing capture	Bi-ventricular pacing capture documented on 12-lead EKG	one month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EBR Systems, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (ESTIMATE): July 23, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: electrical stimulation; Cardiac Resynchronization Therapy; cardiac pacing; bi-ventricular pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Ventricular Dysfunction
• Other Study ID Numbers: EBR-02494; CIV-13-04-010803 (OTHER: EUDAMED)