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

• ClinicalTrials.gov Identifier: NCT01294527
• Recruitment Status: Completed
• First Posted: February 11, 2011
• Last Update Posted: February 8, 2017
• Sponsor: EBR Systems, Inc.
• Information provided by (Responsible Party): EBR Systems, Inc.

Tracking Information

• First Submitted Date: February 8, 2011
• First Posted Date: February 11, 2011
• Last Update Posted Date: February 8, 2017
• Study Start Date: February 2011
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Heart Failure
• Ventricular Dysfunction
• Cardiomyopathy

Intervention

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

Experimental: Implant

Implant of the WiCS-LV system

Intervention: Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT

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.
• Auricchio 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2017): 17
• Original Estimated Enrollment (submitted: February 10, 2011): 100
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Netherlands, Switzerland

Administrative Information

• NCT Number: NCT01294527
• Other Study ID Numbers: EBR-00980
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: EBR Systems, Inc.
• Original Responsible Party: Debra S. Echt, MD; Chief Medical Officer, EBR Systems, Inc.
• Current Study Sponsor: EBR Systems, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Angelo Auricchio, MD; Fondazione Cardiocentro, Lugano CH

• PRS Account: EBR Systems, Inc.
• Verification Date: February 2017