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.

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Ventricular Dysfunction; Cardiomyopathy	Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: February 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: October 2016

Arms and Interventions

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 Name: WiCS-LV system

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: EBR Systems, Inc.
• ClinicalTrials.gov Identifier: NCT01294527
• Other Study ID Numbers: EBR-00980
• First Posted: February 11, 2011
• Last Update Posted: February 8, 2017
• Last Verified: February 2017

Keywords provided by EBR Systems, Inc.:

Cardiac Resynchronization Therapy; cardiac pacing; electrical stimulation; bi-ventricular pacing

Additional relevant MeSH terms:

Cardiomyopathies; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases