Heart FailureWiSE-CRTNCT01294527
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
A study testing Wireless cardiac stimulator implant to pace the left ventricle for CRT in people with Heart Failure and Ventricular Dysfunction, run by EBR Systems, Inc. at 10 sites in 4 countries.
Trial summary
The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Cardiomyopathy
- What is being tested?
- Wireless cardiac stimulator implant to pace the left ventricle for CRT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Feb 2011to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:
- Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
- Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
- Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"
Who cannot join
- Inability to comply with the study follow-up or other study requirements
- Contraindication to heparin
- Contraindication to both chronic anticoagulants and antiplatelet agents
- Contraindication to iodinated contrast agents
- Intracardiac thrombus by transesophageal echocardiography
- Age less than 18 years
Show all 13Show fewer
- Attempted IPG implant within 3 days
- Life expectancy of < 12 months
- Chronic hemodialysis
- Myocardial infarction within one month
- Major cardiac surgery within one month
- Female of childbearing potential, pregnant, or breastfeeding
- Noncardiac implanted electrical stimulation therapy devices
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany5 sites
Kerckhoff-Klinik
Bad Nauheim
Herzzentrum Brandenburg
Bernau
Klinium Coburg gGmbH
Coburg
Facharztzentrum Dresden-Neustadt GbR
Dresden
Herzzentrum Leipzig GmbH
Leipzig
France2 sites
Nouvelles Clinicques Nantaises
Nantes
Hospital Pontchaillou-CHU
Rennes
Netherlands2 sites
Leiden University Medical Centre
Leiden
Isala Klinieken Zwolle
Zwolle
About this study
Official title: Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.
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, Cardiomyopathy
- Being tested
- Wireless cardiac stimulator implant to pace the left ventricle for CRT
- Keywords
- Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless cardiac stimulator implant to pace the left ventricle for CRTDevice
Also called WiCS-LV system
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: Wireless cardiac stimulator implant to pace the left ventricle for CRT |
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 (8)
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
Left ventricular pacing capture
Left ventricular pacing capture documented on 12-lead EKG
Measured: 1, 3, and 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Measured: 3 and 6 months
Bi-ventricular pacing capture
Bi-ventricular pacing capture on 24 hour ambulatory monitoring
Measured: 1, 3, and 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
Change in blood laboratory Brain Natriuretic Peptide
change in NT-proBNP level
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 posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- EBR Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelo Auricchio, MD, Principal investigator, Fondazione Cardiocentro, Lugano CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294527
- Sponsor's protocol ID
- EBR-00980
- Acronym
- WiSE-CRT
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2011
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Auricchio A, Delnoy PP, Butter C, Brachmann J, Van Erven L, Spitzer S, Moccetti T, Seifert M, Markou T, Laszo K, Regoli F; Collaborative Study Group. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4.
PubMed 24497573Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C; collaborative study group. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013 Aug;15(8):1191-7. doi: 10.1093/europace/eut124. Epub 2013 May 23.
PubMed 23703364
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01294527
- Acronym / sponsor ID
- WiSE-CRT / EBR-00980
- Conditions
- Heart Failure, Ventricular Dysfunction, Cardiomyopathy
- Keywords
- Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EBR Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Feb 2011 (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 WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.
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: Wireless cardiac stimulator implant to pace the left ventricle for CRTImplant of the WiCS-LV system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:
- Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
- Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
- Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"
Key exclusion criteria (13 listed)
- Inability to comply with the study follow-up or other study requirements
- Contraindication to heparin
- Contraindication to both chronic anticoagulants and antiplatelet agents
- Contraindication to iodinated contrast agents
- Intracardiac thrombus by transesophageal echocardiography
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 |
|---|---|---|
| Wireless cardiac stimulator implant to pace the left ventricle for CRTAlso: WiCS-LV systemTransvascular 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
8 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
Left ventricular pacing capture
Time frame: 1, 3, and 6 months
Bi-ventricular pacing capture
Time frame: 3 and 6 months
Bi-ventricular pacing capture
Time frame: 1, 3, and 6 months
Clinical composite score
Time frame: 6 months
Change in echocardiographic indices
Time frame: 6 months
Change in blood laboratory Brain Natriuretic Peptide
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 8 Feb 2017.
- Derived from this study: PubMed 24497573Auricchio A, Delnoy PP, Butter C, Brachmann J, Van Erven L, Spitzer S, Moccetti T, Seifert M, Markou T, Laszo K, Regoli F; Collaborative Study Group. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014 May;16(5):681-8. doi: 10.1093/europace/eut435. Epub 2014 Feb 4.
- Derived from this study: PubMed 23703364Auricchio A, Delnoy PP, Regoli F, Seifert M, Markou T, Butter C; collaborative study group. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013 Aug;15(8):1191-7. doi: 10.1093/europace/eut124. Epub 2013 May 23.
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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.
Angelo Auricchio, MD principal investigator
Fondazione Cardiocentro, Lugano CH
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless cardiac stimulator implant to pace the left ventricle for CRT in people with Heart Failure and Ventricular Dysfunction, run by EBR Systems, Inc. at 10 sites in 4 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 4 inclusion and 13 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 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, France, Netherlands, Switzerland. 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 NCT01294527, which also lists 2 linked publications.
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 8 Feb 2017.