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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 : Completed
First Posted : July 23, 2013
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

Tracking Information
First Submitted Date  ICMJE July 19, 2013
First Posted Date  ICMJE July 23, 2013
Last Update Posted Date July 9, 2020
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2013)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of Electrodes Implanted in the Left Ventricle
Official Title  ICMJE Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Ventricular Dysfunction
  • Cardiomyopathies
  • Heart Diseases
  • Cardiovascular Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Implant
Implant of the WiCS-LV system
Intervention: Device: WiCS-LV system
Publications * Reddy VY, Miller MA, Neuzil P, Søgaard 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2013)
40
Actual Study Completion Date  ICMJE November 2019
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Denmark
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01905670
Other Study ID Numbers  ICMJE EBR-02494
CIV-13-04-010803 ( Other Identifier: EUDAMED )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party EBR Systems, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE EBR Systems, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EBR Systems, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP