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History of Changes for Study: NCT01294527
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)
Latest version (submitted February 6, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 10, 2011 None (earliest Version on record)
2 October 11, 2011 Recruitment Status, Study Status and Contacts/Locations
3 January 30, 2012 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
4 May 2, 2012 Recruitment Status, Study Status and Contacts/Locations
5 March 6, 2014 Study Status and Study Design
6 November 18, 2015 Study Status
7 February 6, 2017 Recruitment Status, Study Status and Study Design
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Study NCT01294527
Submitted Date:  February 10, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: EBR-00980
Brief Title: Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)
Official Title: Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2011
Overall Status: Recruiting
Study Start: February 2011
Primary Completion: February 2012 [Anticipated]
Study Completion: July 2012 [Anticipated]
First Submitted: February 8, 2011
First Submitted that
Met QC Criteria:
February 10, 2011
First Posted: February 11, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 10, 2011
Last Update Posted: February 11, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: EBR Systems, Inc.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Heart Failure
Ventricular Dysfunction
Cardiomyopathy
Keywords: Cardiac Resynchronization Therapy
cardiac pacing
electrical stimulation
bi-ventricular pacing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • WiCS-LV system
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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.
3. Bi-ventricular pacing capture
[ Time Frame: one month ]

Bi-ventricular pacing capture documented on 12-lead EKG
Secondary Outcome Measures:
1. 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.
2. Number of patients with serious adverse events as a measure of safety
[ Time Frame: 6 months ]

3. Left ventricular pacing capture
[ Time Frame: 1, 3, and 6 months ]

Left ventricular pacing capture documented on 12-lead EKG
4. Bi-ventricular pacing capture
[ Time Frame: 3 and 6 months ]

Bi-ventricular pacing capture documented on 12-lead EKG
5. Bi-ventricular pacing capture
[ Time Frame: 1, 3, and 6 months ]

Bi-ventricular pacing capture on 24 hour ambulatory monitoring
6. Clinical composite score
[ Time Frame: 6 months ]

Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
7. Change in echocardiographic indices
[ Time Frame: 6 months ]

change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
8. Change in blood laboratory Brain Natriuretic Peptide
[ Time Frame: 6 months ]

change in NT-proBNP level
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Debra S Echt, MD
Telephone: 408 720 1906 Ext. 223
Email: decht@ebrsystemsinc.com
Study Officials: Angelo Auricchio, MD
Principal Investigator
Fondazione Cardiocentro, Lugano CH
Locations: France
Nouvelles Clinicques Nantaises
[Not yet recruiting]
Nantes, France
Contact:Contact: Daniel Gras, MD
Contact:Principal Investigator: Daniel Gras, MD
Hospital Pontchaillou-CHU
[Not yet recruiting]
Rennes, France
Contact:Contact: Christophe Leclercq, MD
Contact:Principal Investigator: Christophe Leclercq, MD
Contact:Sub-Investigator: Jean-Claude Daubert, MD
Germany
Kerckhoff-Klinik
[Recruiting]
Bad Nauheim, Germany
Contact:Contact: Johannes Sperzel, MD
Contact:Principal Investigator: Johannes Sperzel, MD
Herzzentrum Brandenburg
[Recruiting]
Bernau, Germany
Contact:Contact: Christian Butter, MD
Contact:Principal Investigator: Christian Butter, MD
Klinium Coburg gGmbH
[Recruiting]
Coburg, Germany
Contact:Contact: Johannes Brachmann, MD
Contact:Principal Investigator: Johannes Brachmann, MD
Facharztzentrum Dresden-Neustadt GbR
[Recruiting]
Dresden, Germany
Contact:Contact: Stefan Spitzer, MD
Contact:Principal Investigator: Stefan Spitzer, MD
Herzzentrum Leipzig GmbH
[Not yet recruiting]
Leipzig, Germany
Contact:Contact: Gerhard Hindricks, MD
Contact:Principal Investigator: Gerhard Hindricks, MD
Netherlands
Leiden University Medical Centre
[Not yet recruiting]
Leiden, Netherlands
Contact:Contact: Lieselot van Erven, MD
Contact:Principal Investigator: Martin Schalij, MD
Contact:Principal Investigator: Lieselot van Erven, MD
Isala Klinieken Zwolle
[Recruiting]
Zwolle, Netherlands
Contact:Contact: Peter Paul Delnoy, MD
Contact:Principal Investigator: Peter Paul Delnoy, MD
Switzerland
Cardiocentro Ticini
[Not yet recruiting]
Lugano, Switzerland
Contact:Contact: Angelo Auricchio, MD
Contact:Principal Investigator: Tiziano Mocetti, MD
Contact:Sub-Investigator: Angelo Auricchio, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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