Multicenter, Prospective Evaluation of Performance, Safety, and Surveillance of the WiCS-LV System in Patients Indicated for Cardiac Resynchronization Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- EBR Systems, Inc.
- Enrollment
- 17
- Locations
- 10
- Primary Endpoint
- Number of patients with device-related adverse events as a measure of safety
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of patients with device-related adverse events as a measure of safety
Time Frame: 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
Time Frame: 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
Time Frame: one month
Bi-ventricular pacing capture documented on 12-lead EKG
Secondary Outcomes
- 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(1, 3, and 6 months)
- Clinical composite score(6 months)
- Change in echocardiographic indices(6 months)
- Change in blood laboratory Brain Natriuretic Peptide(6 months)