Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

NCT01294527 | Completed DMC

• 1 other identifier: EBR-00980
• Study Type: interventional
• Target: 17
• Locations: 4 countries
• Sites: 10

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.

Conditions

Heart Failure; Ventricular Dysfunction; Cardiomyopathy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Number of patients with device-related adverse events as a measure of safety

  6 months

• Number of patients with serious adverse events as a measure of safety

  6 months

• Left ventricular pacing capture

  1, 3, and 6 months

• Bi-ventricular pacing capture

  3 and 6 months

• Bi-ventricular pacing capture

  1, 3, and 6 months

Study Arms (1)

Implant

EXPERIMENTAL

Implant of the WiCS-LV system

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

Interventions

Wireless cardiac stimulator implant to pace the left ventricle for CRT DEVICE

Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator

Also known as: WiCS-LV system

Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:
• Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
• Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
• 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"

You may not qualify if:

• Inability to comply with the study follow-up or other study requirements
• Contraindication to heparin
• Contraindication to both chronic anticoagulants and antiplatelet agents
• Contraindication to iodinated contrast agents
• Intracardiac thrombus by transesophageal echocardiography
• Age less than 18 years
• Attempted IPG implant within 3 days
• Life expectancy of \< 12 months
• Chronic hemodialysis
• Myocardial infarction within one month
• Major cardiac surgery within one month
• Female of childbearing potential, pregnant, or breastfeeding
• Noncardiac implanted electrical stimulation therapy devices

Sponsors & Collaborators

• EBR Systems, Inc.: lead

Study Sites (10)

Nouvelles Clinicques Nantaises

Nantes, France

Location

Hospital Pontchaillou-CHU

Rennes, France

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

Herzzentrum Brandenburg

Bernau, Germany

Location

Klinium Coburg gGmbH

Coburg, Germany

Location

Facharztzentrum Dresden-Neustadt GbR

Dresden, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Leiden University Medical Centre

Leiden, Netherlands

Location

Isala Klinieken Zwolle

Zwolle, Netherlands

Location

Cardiocentro Ticini

Lugano, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 24497573 DERIVED

• 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.

  PMID: 23703364 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Angelo Auricchio, MD

  Fondazione Cardiocentro, Lugano CH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2016
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

NL (2); FR (2); DE (5); CH (1)