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History of Changes for Study: NCT01905670
Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV)
Latest version (submitted July 7, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 22, 2013 None (earliest Version on record)
2 October 18, 2013 Contacts/Locations and Study Status
3 February 9, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 May 20, 2015 Study Status
5 September 27, 2016 Study Status
6 February 24, 2018 Study Status and Contacts/Locations
7 July 7, 2020 Recruitment Status and Study Status
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Study NCT01905670
Submitted Date:  July 22, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: EBR-02494
Brief Title: Safety and Performance of Electrodes Implanted in the Left Ventricle (SELECT-LV)
Official Title: Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Secondary IDs: CIV-13-04-010803 [EUDAMED]
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Recruiting
Study Start: July 2013
Primary Completion: May 2014 [Anticipated]
Study Completion: September 2014 [Anticipated]
First Submitted: July 19, 2013
First Submitted that
Met QC Criteria:
July 22, 2013
First Posted: July 23, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 22, 2013
Last Update Posted: July 23, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: EBR Systems, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
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.

Open or close this module Conditions
Conditions: Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Keywords: Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations: Czech Republic
Na Homolce Hospital
[Recruiting]
Prague, Czech Republic, 150 30
Contact:Contact: Petr Neužil, M.D., Ph.D. +420 257 272 221
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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