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

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ClinicalTrials.gov Identifier: NCT01905670
Recruitment Status : Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 39 participants
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
Estimated Study Completion Date : February 2020

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 Name: Implant




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Bi-ventricular pacing capture [ Time Frame: one month ]
    Bi-ventricular pacing capture documented on 12-lead EKG


Secondary Outcome Measures :
  1. 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.

  2. Number of patients with serious adverse events as a measure of safety [ Time Frame: 6 months ]
  3. Bi-ventricular pacing capture [ Time Frame: 6 months ]
    Bi-ventricular pacing capture documented on 12-lead EKG

  4. Clinical composite score [ Time Frame: 6 months ]
    Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment

  5. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
EBR Systems, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EBR Systems, Inc.
ClinicalTrials.gov Identifier: NCT01905670     History of Changes
Other Study ID Numbers: EBR-02494
CIV-13-04-010803 ( Other Identifier: EUDAMED )
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by EBR Systems, Inc.:
Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Cardiomyopathies
Ventricular Dysfunction