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

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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Locations

Czechia
Na Homolce Hospital
Prague, Czechia, 150 30
Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100

Sponsors and Collaborators

EBR Systems, Inc.

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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