Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy (WiSE-CRT)
This study is ongoing, but not recruiting participants.
Sponsor:
EBR Systems, Inc.
Information provided by (Responsible Party):
EBR Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01294527
First received: February 8, 2011
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Heart Failure Ventricular Dysfunction Cardiomyopathy |
Device: Wireless cardiac stimulator implant to pace the left ventricle for CRT |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by EBR Systems, Inc.:
Primary Outcome Measures:
- Number of patients with device-related adverse events as a measure of safety [ Time Frame: 24 hour peri-operative and one month ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
- Bi-ventricular pacing capture [ Time Frame: one month ] [ Designated as safety issue: No ]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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Left ventricular pacing capture [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]Left ventricular pacing capture documented on 12-lead EKG
- Bi-ventricular pacing capture [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]Bi-ventricular pacing capture documented on 12-lead EKG
- Bi-ventricular pacing capture [ Time Frame: 1, 3, and 6 months ] [ Designated as safety issue: No ]Bi-ventricular pacing capture on 24 hour ambulatory monitoring
- Clinical composite score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
- Change in echocardiographic indices [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]change in NT-proBNP level
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294527
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
No publications provided
| Responsible Party: | EBR Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT01294527 History of Changes |
| Other Study ID Numbers: | EBR-00980 |
| Study First Received: | February 8, 2011 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: Ministry of Health, Welfare and Sport Switzerland: Swissmedic |
Keywords provided by EBR Systems, Inc.:
|
Cardiac Resynchronization Therapy cardiac pacing electrical stimulation bi-ventricular pacing |
Additional relevant MeSH terms:
|
Heart Failure Ventricular Dysfunction Cardiomyopathies Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013