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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Ventricular Dysfunction; Cardiomyopathy
• Intervention / Treatment: Device: Wireless cardiac stimulator implant to pace the left ventricle 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
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nouvelles Clinicques Nantaises
  • Rennes, France
    • Hospital Pontchaillou-CHU
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-klinik
  • Bernau, Germany
    • Herzzentrum Brandenburg
  • Coburg, Germany
    • Klinium Coburg gGmbH
  • Dresden, Germany
    • Facharztzentrum Dresden-Neustadt GbR
  • Leipzig, Germany
    • Herzzentrum Leipzig GmbH
• Netherlands
  • Leiden, Netherlands
    • Leiden University Medical Centre
  • Zwolle, Netherlands
    • Isala Klinieken Zwolle
• Switzerland
  • Lugano, Switzerland
    • Cardiocentro Ticini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with device-related adverse events as a measure of safety	Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.	24 hour peri-operative and one month
Number of patients with procedure-related adverse events as a measure of safety	Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.	24 hour perioperative and one month
Bi-ventricular pacing capture	Bi-ventricular pacing capture documented on 12-lead EKG	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with device-related adverse events as a measure of safety	Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.	6 months
Number of patients with serious adverse events as a measure of safety		6 months
Left ventricular pacing capture	Left ventricular pacing capture documented on 12-lead EKG	1, 3, and 6 months
Bi-ventricular pacing capture	Bi-ventricular pacing capture documented on 12-lead EKG	3 and 6 months
Bi-ventricular pacing capture	Bi-ventricular pacing capture on 24 hour ambulatory monitoring	1, 3, and 6 months
Clinical composite score	Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment	6 months
Change in echocardiographic indices	change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction	6 months
Change in blood laboratory Brain Natriuretic Peptide	change in NT-proBNP level	6 months

Collaborators and Investigators

• Sponsor: EBR Systems, Inc.
• Investigators: Principal Investigator: Angelo Auricchio, MD, Fondazione Cardiocentro, Lugano CH

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: electrical stimulation; Cardiac Resynchronization Therapy; cardiac pacing; bi-ventricular pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Ventricular Dysfunction
• Other Study ID Numbers: EBR-00980