Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV)
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ClinicalTrials.gov Identifier: NCT01905670 |
Recruitment Status :
Completed
First Posted : July 23, 2013
Last Update Posted : July 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases | Device: WiCS-LV system | Not Applicable |
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 (Clinical Trial) |
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 : | July 2013 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | November 2019 |
Arm | Intervention/treatment |
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Experimental: Implant
Implant of the WiCS-LV system
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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 Name: Implant |
- Number of patients with device-related adverse events as a measure of safety [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: one month ]Bi-ventricular pacing capture documented on 12-lead EKG
- Number of patients with device-related adverse events as a measure of safety [ Time Frame: 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 [ Time Frame: 6 months ]
- Bi-ventricular pacing capture [ Time Frame: 6 months ]Bi-ventricular pacing capture documented on 12-lead EKG
- Clinical composite score [ Time Frame: 6 months ]Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
- Change in echocardiographic indices [ Time Frame: 6 months ]change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905670
Czechia | |
Na Homolce Hospital | |
Prague, Czechia, 150 30 | |
Denmark | |
Aalborg University Hospital | |
Aalborg, Denmark, 9100 |
Responsible Party: | EBR Systems, Inc. |
ClinicalTrials.gov Identifier: | NCT01905670 |
Other Study ID Numbers: |
EBR-02494 CIV-13-04-010803 ( Other Identifier: EUDAMED ) |
First Posted: | July 23, 2013 Key Record Dates |
Last Update Posted: | July 9, 2020 |
Last Verified: | February 2018 |
Cardiac Resynchronization Therapy cardiac pacing electrical stimulation bi-ventricular pacing |
Cardiovascular Diseases Heart Diseases Cardiomyopathies Ventricular Dysfunction |