Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01905670|
Recruitment Status : Unknown
Verified February 2018 by EBR Systems, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : February 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||February 2020|
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 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
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
|Na Homolce Hospital|
|Prague, Czechia, 150 30|
|Aalborg University Hospital|
|Aalborg, Denmark, 9100|