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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EBR Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01294527
First received: February 8, 2011
Last updated: March 6, 2014
Last verified: March 2014

February 8, 2011
March 6, 2014
February 2011
April 2012   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
  • Bi-ventricular pacing capture [ Time Frame: one month ] [ Designated as safety issue: No ]
    Bi-ventricular pacing capture documented on 12-lead EKG
Same as current
Complete list of historical versions of study NCT01294527 on ClinicalTrials.gov Archive Site
  • Number of patients with device-related adverse events as a measure of safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Left ventricular pacing capture [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
    Left ventricular pacing capture documented on 12-lead EKG
  • Bi-ventricular pacing capture [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Bi-ventricular pacing capture documented on 12-lead EKG
  • Bi-ventricular pacing capture [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]
    Bi-ventricular pacing capture on 24 hour ambulatory monitoring
  • Clinical composite score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
  • Change in echocardiographic indices [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    change in NT-proBNP level
Same as current
Not Provided
Not Provided
 
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Ventricular Dysfunction
  • Cardiomyopathy
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
Experimental: Implant
Implant of the WiCS-LV system
Intervention: Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
October 2016
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands,   Switzerland
 
NCT01294527
EBR-00980
Yes
EBR Systems, Inc.
EBR Systems, Inc.
Not Provided
Principal Investigator: Angelo Auricchio, MD Fondazione Cardiocentro, Lugano CH
EBR Systems, Inc.
March 2014

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