Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

Not Applicable

Completed

• Conditions: Ventricular Dysfunction; Heart Failure; Cardiomyopathy

• Registration Number: NCT01294527
• Lead Sponsor: EBR Systems, Inc.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-04
• Study Completion: 2016-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with device-related adverse events as a measure of safety	24 hour peri-operative and one month	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	24 hour perioperative and one month	Procedure-related adverse events are those which occur during the WiCS-LV system implant procedure.
Bi-ventricular pacing capture	one month	Bi-ventricular pacing capture documented on 12-lead EKG

Secondary Outcome Measures

Name	Time	Method
Left ventricular pacing capture	1, 3, and 6 months	Left ventricular pacing capture documented on 12-lead EKG
Bi-ventricular pacing capture	1, 3, and 6 months	Bi-ventricular pacing capture on 24 hour ambulatory monitoring
Clinical composite score	6 months	Composite of all cause mortality, heart failure hospitalization, NYHA class, and patient global assessment
Change in echocardiographic indices	6 months	change in left-ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction
Change in blood laboratory Brain Natriuretic Peptide	6 months	change in NT-proBNP level
Number of patients with device-related adverse events as a measure of safety	6 months	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	6 months

Trial Locations

Locations (10)

Nouvelles Clinicques Nantaises; 🇫🇷 Nantes, France

Hospital Pontchaillou-CHU; 🇫🇷 Rennes, France

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

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

Isala Klinieken Zwolle; 🇳🇱 Zwolle, Netherlands

Cardiocentro Ticini; 🇨🇭 Lugano, Switzerland