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

Primary Purpose

Heart Failure, Ventricular Dysfunction, Cardiomyopathies

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

WiCS-LV system

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.
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:

Inability to comply with the study follow-up or other study requirements
History of chronic alcohol/drug abuse and currently using alcohol/drugs
Non-ambulatory (or unstable) NYHA class 4
Contraindication to heparin
Contraindication to both chronic anticoagulants and antiplatelet agents
Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents)
Thrombocytopenia (platelet count <150,000)
Contraindication to iodinated contrast agents
Intracardiac thrombus by transesophageal echocardiography
Age less than 18 years or greater than 75
Attempted IPG implant within 3 days
Life expectancy of less than 12 months
Chronic hemodialysis
Stage 4 or 5 renal dysfunction defined as GFR <30
Grade 4 mitral valve regurgitation
Myocardial infarction within one month
Major cardiac surgery within one month
History of a pericardial effusion in prior procedures
Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable)
Non-cardiac implanted electrical stimulation therapy devices

Sites / Locations

Na Homolce Hospital
Aalborg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant

Arm Description

Implant of the WiCS-LV system

Outcomes

Primary Outcome Measures

Number of patients with device-related adverse events as a measure of safety

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

Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.

Bi-ventricular pacing capture

Bi-ventricular pacing capture documented on 12-lead EKG

Secondary Outcome Measures

Number of patients with device-related adverse events as a measure of safety

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

Bi-ventricular pacing capture

Bi-ventricular pacing capture documented on 12-lead EKG

Clinical composite score

Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment

Change in echocardiographic indices

change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction

Full Information

NCT ID

NCT01905670

First Posted

July 19, 2013

Last Updated

July 7, 2020

Sponsor

EBR Systems, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01905670

Brief Title

Safety and Performance of Electrodes Implanted in the Left Ventricle

Acronym

SELECT-LV

Official Title

Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EBR Systems, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases

Keywords

Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implant

Arm Type

Experimental

Arm Description

Implant of the WiCS-LV system

Intervention Type

Device

Intervention Name(s)

WiCS-LV system

Other Intervention Name(s)

Implant

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with device-related adverse events as a measure of safety

Description

Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.

Time Frame

24 hour peri-operative and one month

Title

Number of patients with procedure-related adverse events as a measure of safety

Description

Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.

Time Frame

24 hour perioperative and one month

Title

Bi-ventricular pacing capture

Description

Bi-ventricular pacing capture documented on 12-lead EKG

Time Frame

one month

Secondary Outcome Measure Information:

Title

Number of patients with device-related adverse events as a measure of safety

Description

Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.

Time Frame

6 months

Title

Number of patients with serious adverse events as a measure of safety

Time Frame

6 months

Title

Bi-ventricular pacing capture

Description

Bi-ventricular pacing capture documented on 12-lead EKG

Time Frame

6 months

Title

Clinical composite score

Description

Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment

Time Frame

6 months

Title

Change in echocardiographic indices

Description

change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: 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. 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: Inability to comply with the study follow-up or other study requirements History of chronic alcohol/drug abuse and currently using alcohol/drugs Non-ambulatory (or unstable) NYHA class 4 Contraindication to heparin Contraindication to both chronic anticoagulants and antiplatelet agents Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents) Thrombocytopenia (platelet count <150,000) Contraindication to iodinated contrast agents Intracardiac thrombus by transesophageal echocardiography Age less than 18 years or greater than 75 Attempted IPG implant within 3 days Life expectancy of less than 12 months Chronic hemodialysis Stage 4 or 5 renal dysfunction defined as GFR <30 Grade 4 mitral valve regurgitation Myocardial infarction within one month Major cardiac surgery within one month History of a pericardial effusion in prior procedures Female of childbearing potential, pregnant, or breastfeeding (a pregnancy test will be obtained where applicable) Non-cardiac implanted electrical stimulation therapy devices

Facility Information:

Facility Name

Na Homolce Hospital

City

Prague

ZIP/Postal Code

150 30

Country

Czechia

Facility Name

Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28449772

Citation

Reddy VY, Miller MA, Neuzil P, Sogaard 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.

Results Reference

derived

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Safety and Performance of Electrodes Implanted in the Left Ventricle

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