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Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01294527
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.

Tracking Information
First Submitted Date  ICMJE February 8, 2011
First Posted Date  ICMJE February 11, 2011
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • 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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • 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 ]
  • Left ventricular pacing capture [ Time Frame: 1, 3, and 6 months ]
    Left ventricular pacing capture documented on 12-lead EKG
  • Bi-ventricular pacing capture [ Time Frame: 3 and 6 months ]
    Bi-ventricular pacing capture documented on 12-lead EKG
  • Bi-ventricular pacing capture [ Time Frame: 1, 3, and 6 months ]
    Bi-ventricular pacing capture on 24 hour ambulatory monitoring
  • 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
  • Change in blood laboratory Brain Natriuretic Peptide [ Time Frame: 6 months ]
    change in NT-proBNP level
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
Official Title  ICMJE Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Ventricular Dysfunction
  • Cardiomyopathy
Intervention  ICMJE Device: 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: WiCS-LV system
Study Arms  ICMJE Experimental: Implant
Implant of the WiCS-LV system
Intervention: Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2011)
100
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:

  1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
  2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
  3. 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"

Exclusion Criteria:

  1. Inability to comply with the study follow-up or other study requirements
  2. Contraindication to heparin
  3. Contraindication to both chronic anticoagulants and antiplatelet agents
  4. Contraindication to iodinated contrast agents
  5. Intracardiac thrombus by transesophageal echocardiography
  6. Age less than 18 years
  7. Attempted IPG implant within 3 days
  8. Life expectancy of < 12 months
  9. Chronic hemodialysis
  10. Myocardial infarction within one month
  11. Major cardiac surgery within one month
  12. Female of childbearing potential, pregnant, or breastfeeding
  13. Noncardiac implanted electrical stimulation therapy devices
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Netherlands,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01294527
Other Study ID Numbers  ICMJE EBR-00980
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party EBR Systems, Inc.
Original Responsible Party Debra S. Echt, MD; Chief Medical Officer, EBR Systems, Inc.
Current Study Sponsor  ICMJE EBR Systems, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angelo Auricchio, MD Fondazione Cardiocentro, Lugano CH
PRS Account EBR Systems, Inc.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP