Heart FailureSELECT-LVNCT01905670
Safety and Performance of Electrodes Implanted in the Left Ventricle
A study testing WiCS-LV system in people with Heart Failure and Ventricular Dysfunction, run by EBR Systems, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies
- What is being tested?
- WiCS-LV system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2013to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
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.
Read the 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.
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
- Being tested
- WiCS-LV system
- Keywords
- Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WiCS-LV systemDevice
Also called Implant
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
| Study group | Role | What they receive |
|---|---|---|
| Implant | Experimental | Implant of the WiCS-LV system Receives: Device: WiCS-LV system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour peri-operative and one month
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.
Measured: 24 hour perioperative and one month
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Measured: one month
Secondary outcomes (5)
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.
Measured: 6 months
Number of patients with serious adverse events as a measure of safety
Measured: 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Measured: 6 months
Clinical composite score
Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
Measured: 6 months
Change in echocardiographic indices
change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- EBR Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905670
- Sponsor's protocol ID
- EBR-02494
- Other IDs
- CIV-13-04-010803
- Acronym
- SELECT-LV
- Status last verified
- Feb 2018
- First submitted
- 19 Jul 2013
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28449772
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Evaluation of Safety and Performance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01905670
- Acronym / sponsor ID
- SELECT-LV / EBR-02494
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
- Keywords
- Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- EBR Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: WiCS-LV systemImplant of the WiCS-LV system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WiCS-LV systemAlso: ImplantWireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator | Device | Implant |
Primary outcome
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
5 secondary outcomes
Number of patients with device-related adverse events as a measure of safety
Time frame: 6 months
Number of patients with serious adverse events as a measure of safety
Time frame: 6 months
Bi-ventricular pacing capture
Time frame: 6 months
Clinical composite score
Time frame: 6 months
Change in echocardiographic indices
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 28449772Reddy 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WiCS-LV system in people with Heart Failure and Ventricular Dysfunction, run by EBR Systems, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with device-related adverse events as a measure of safety (time frame: 24 hour peri-operative and one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.