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
  Purpose

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.


Condition Intervention Phase
Heart Failure
Ventricular Dysfunction
Cardiomyopathy
Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy

Resource links provided by NLM:


Further study details as provided by EBR Systems, Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: October 2016
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implant
Implant of the WiCS-LV system
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294527

Locations
France
Nouvelles Clinicques Nantaises
Nantes, France
Hospital Pontchaillou-CHU
Rennes, France
Germany
Kerckhoff-Klinik
Bad Nauheim, Germany
Herzzentrum Brandenburg
Bernau, Germany
Klinium Coburg gGmbH
Coburg, Germany
Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
Switzerland
Cardiocentro Ticini
Lugano, Switzerland
Sponsors and Collaborators
EBR Systems, Inc.
Investigators
Principal Investigator: Angelo Auricchio, MD Fondazione Cardiocentro, Lugano CH
  More Information

No publications provided by EBR Systems, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EBR Systems, Inc.
ClinicalTrials.gov Identifier: NCT01294527     History of Changes
Other Study ID Numbers: EBR-00980
Study First Received: February 8, 2011
Last Updated: March 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Ministry of Health, Welfare and Sport
Switzerland: Swissmedic

Keywords provided by EBR Systems, Inc.:
Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014