Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Ventricular Dysfunction Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Implant

Implant of the WiCS-LV system

Group Type EXPERIMENTAL

Wireless cardiac stimulator implant to pace the left ventricle for CRT

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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WiCS-LV system

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No