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

Sponsor

EBR Systems, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01905670

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

19.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases	Device: WiCS-LV system	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.
Bi-ventricular pacing capture [one month]
Bi-ventricular pacing capture documented on 12-lead EKG

Secondary Outcome Measures

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]
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
Change in echocardiographic indices [6 months]
change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.
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:

Inability to comply with the study follow-up or other study requirements
History of chronic alcohol/drug abuse and currently using alcohol/drugs
Non-ambulatory (or unstable) NYHA class 4
Contraindication to heparin
Contraindication to both chronic anticoagulants and antiplatelet agents
Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
Thrombocytopenia (platelet count <150,000)
Contraindication to iodinated contrast agents
Intracardiac thrombus by transesophageal echocardiography
Age less than 18 years or greater than 75
Attempted IPG implant within 3 days
Life expectancy of less than 12 months
Chronic hemodialysis
Stage 4 or 5 renal dysfunction defined as GFR <30
Grade 4 mitral valve regurgitation
Myocardial infarction within one month
Major cardiac surgery within one month
History of a pericardial effusion in prior procedures
Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable)
Non-cardiac implanted electrical stimulation therapy devices