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

• ClinicalTrials.gov Identifier: NCT01905670
• Recruitment Status: Completed
• First Posted: July 23, 2013
• Last Update Posted: July 9, 2020
• Sponsor: EBR Systems, Inc.
• Information provided by (Responsible Party): EBR Systems, Inc.

Tracking Information

• First Submitted Date: July 19, 2013
• First Posted Date: July 23, 2013
• Last Update Posted Date: July 9, 2020
• Study Start Date: July 2013
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Performance of Electrodes Implanted in the Left Ventricle
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Heart Failure
• Ventricular Dysfunction
• Cardiomyopathies
• Heart Diseases
• Cardiovascular Diseases

Intervention

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2015): 39
• Original Estimated Enrollment (submitted: July 22, 2013): 40
• Actual Study Completion Date: November 2019
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia, Denmark
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01905670
• Other Study ID Numbers: EBR-02494; CIV-13-04-010803 ( Other Identifier: EUDAMED )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: EBR Systems, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: EBR Systems, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: EBR Systems, Inc.
• Verification Date: February 2018