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

Primary Purpose

Heart Failure, Ventricular Dysfunction, Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Wireless cardiac stimulator implant to pace the left ventricle for CRT
Sponsored by
EBR Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nouvelles Clinicques Nantaises
  • Hospital Pontchaillou-CHU
  • Kerckhoff-Klinik
  • Herzzentrum Brandenburg
  • Klinium Coburg gGmbH
  • Facharztzentrum Dresden-Neustadt GbR
  • Herzzentrum Leipzig GmbH
  • Leiden University Medical Centre
  • Isala Klinieken Zwolle
  • Cardiocentro Ticini

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implant

Arm Description

Implant of the WiCS-LV system

Outcomes

Primary Outcome Measures

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.
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.
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG

Secondary Outcome Measures

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.
Number of patients with serious adverse events as a measure of safety
Left ventricular pacing capture
Left ventricular pacing capture documented on 12-lead EKG
Bi-ventricular pacing capture
Bi-ventricular pacing capture documented on 12-lead EKG
Bi-ventricular pacing capture
Bi-ventricular pacing capture on 24 hour ambulatory monitoring
Clinical composite score
Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
Change in echocardiographic indices
change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
Change in blood laboratory Brain Natriuretic Peptide
change in NT-proBNP level

Full Information

First Posted
February 8, 2011
Last Updated
February 6, 2017
Sponsor
EBR Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01294527
Brief Title
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
Acronym
WiSE-CRT
Official Title
Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EBR Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dysfunction, Cardiomyopathy
Keywords
Cardiac Resynchronization Therapy, cardiac pacing, electrical stimulation, bi-ventricular pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implant
Arm Type
Experimental
Arm Description
Implant of the WiCS-LV system
Intervention Type
Device
Intervention Name(s)
Wireless cardiac stimulator implant to pace the left ventricle for CRT
Other Intervention Name(s)
WiCS-LV system
Intervention Description
Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
Primary Outcome Measure Information:
Title
Number of patients with device-related adverse events as a measure of safety
Description
Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
Time Frame
24 hour peri-operative and one month
Title
Number of patients with procedure-related adverse events as a measure of safety
Description
Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
Time Frame
24 hour perioperative and one month
Title
Bi-ventricular pacing capture
Description
Bi-ventricular pacing capture documented on 12-lead EKG
Time Frame
one month
Secondary Outcome Measure Information:
Title
Number of patients with device-related adverse events as a measure of safety
Description
Device-related adverse events are those in which the WiCS-LV system is directly or indirectly responsible.
Time Frame
6 months
Title
Number of patients with serious adverse events as a measure of safety
Time Frame
6 months
Title
Left ventricular pacing capture
Description
Left ventricular pacing capture documented on 12-lead EKG
Time Frame
1, 3, and 6 months
Title
Bi-ventricular pacing capture
Description
Bi-ventricular pacing capture documented on 12-lead EKG
Time Frame
3 and 6 months
Title
Bi-ventricular pacing capture
Description
Bi-ventricular pacing capture on 24 hour ambulatory monitoring
Time Frame
1, 3, and 6 months
Title
Clinical composite score
Description
Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
Time Frame
6 months
Title
Change in echocardiographic indices
Description
change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
Time Frame
6 months
Title
Change in blood laboratory Brain Natriuretic Peptide
Description
change in NT-proBNP level
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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" Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Auricchio, MD
Organizational Affiliation
Fondazione Cardiocentro, Lugano CH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nouvelles Clinicques Nantaises
City
Nantes
Country
France
Facility Name
Hospital Pontchaillou-CHU
City
Rennes
Country
France
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
Country
Germany
Facility Name
Herzzentrum Brandenburg
City
Bernau
Country
Germany
Facility Name
Klinium Coburg gGmbH
City
Coburg
Country
Germany
Facility Name
Facharztzentrum Dresden-Neustadt GbR
City
Dresden
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
Leiden University Medical Centre
City
Leiden
Country
Netherlands
Facility Name
Isala Klinieken Zwolle
City
Zwolle
Country
Netherlands
Facility Name
Cardiocentro Ticini
City
Lugano
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24497573
Citation
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.
Results Reference
derived
PubMed Identifier
23703364
Citation
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.
Results Reference
derived

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Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

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