Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
Conditions
Interventions
Summary of implant steps:
1. Prepare femoral artery access with introducer and arterial closure device.
2. Administer intravenous heparin to attain an ACT level in the range of
200-250 sec.
3. Intro
Sponsors
EBR Systems Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with standard indications for CRT based upon the most recent ESC/EHRA guidelines AND meeting criteria for one of these two categories: 1. Patients with previously implanted pacemakers or ICD*s and meeting standard indications for CRT but in whom standard CRT is not advisable due to known high risk - referred to as *upgrades*. Justifications for not using standard CRT must be documented in a CRF. 2. Patients in whom coronary sinus lead implantation or attempted implantation for CRT has failed to provide demonstrable therapy benefit - referred to as *untreated* Investigator
Exclusion criteria
Exclusion criteria: Study patients responding to the following criteria are excluded from enrollment: 1. Inability to comply with the study follow-up or other study requirements 2. History of chronic alcohol/drug abuse and currently using alcohol/drugs 3. Non-ambulatory (or unstable) NYHA class 4 4. Contraindication to heparin 5. Contraindication to both chronic anticoagulants and antiplatelet agents 6. Triple anticoagulation therapy (warfarin, clopidogrel, ASA, and other agents) 7. Thrombocytopenia (platelet count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 20.4 Primary endpoint(s) analysis 20.4.1 Safety Primary endpoint - Device-related complications (24 hours perioperative and one month): A primary endpoint for evidence of safety will be the number of patients with major device-related complications. This endpoint will be assessed at two time points, the perioperative device-related complications (from implant to 24 hours post implant) and the one month (30 day) device-related complications (from 24 hours post implant to 30 days post implant). The definition of a major device-related complication is a complication in which the WiCS-LV system is directly or indirectly responsible for a serious adverse event. All serious adverse events will be reviewed and adjudicated by an independent Clinical Events Committee. Primary endpoint - Procedure-related complications (24 hours perioperative and one month): A primary endpoint for evidence of safety will be the number of patients with major procedure-related complications. This endpoint will be assessed at two time points, the perioperative procedure-related complications (from implant to 24 hours post implant) and the one month (30 day) procedure-related complications (from24 hours post implant to 30 days post implant). The definition of a major procedure-related complication is a serious adverse event occurring as a direct result of the implant procedure. All serious adverse events will be reviewed and adjudicated by an independent Clinical Events Committee. 20.4.2 Performance Primary endpoint - bi-ventricular pacing at one month: The primary endpoint for evidence of clinical performance will be chronic bi-ventricular pacing. This will be demonstrated by obtaining 12 lead EKG*s at the 1 month (30 day) follow-up assessment. Twelve lead EKG*s will be obtained without pacing (if the patient is not pacemaker-dependent, during RV pacing (by temporarily programming off the WiCS-LV system), and during bi-ventricular pacing. Bi-ventricular capture wil | — |
Secondary
| Measure | Time frame |
|---|---|
| 20.5 Secondary endpoint(s) analysis 20.5.1 Safety Secondary endpoint - Device-related complications up to 6 months: Device-related complications will be tabulated in the same manner as the primary endpoint, but extended to 6 months post implant. All serious adverse events will be reviewed and adjudicated by an independent Clinical Events Committee. Secondary endpoint - Major complications up to 6 months: All serious adverse events regardless of cause will be tabulated. All serious adverse events will be reviewed and adjudicated by an independent Clinical Events Committee. Surveillance evaluation annually for 5 years: All serious adverse events will be tabulated. Data regarding battery depletion and device replacement will be collected. 20.5.2 Performance Secondary endpoint - left ventricular pacing at one, 2 and 6 months: The secondary endpoint for evidence of clinical performance will be chronic left ventricular pacing. This will be demonstrated by obtaining 12 lead EKG*s at the one, 2 and 6 month follow-up assessments. Normally, the 12 lead EKG will be obtained after temporarily reducing the co-implanted pacemaker rate and operating the WiCS-LV system in temporary VOO mode at a higher rate to capture the left ventricle alone. However, there may be instances where it is clinically preferable to demonstrate left ventricular capture by comparing the paced QRS morphology during bi-ventricular pacing to that during right ventricular pacing alone (by temporarily programming off the WiCS-LV system). Secondary endpoint - bi-ventricular pacing at 2 and 6 months: Bi-ventricular pacing as a secondary endpoint will be demonstrated by obtaining 12 lead EKG*s at the 2 and 6 month follow-up assessments. Twelve lead EKG*s will be obtained without pacing (if the patient is not pacemaker-dependent, during RV pacing (by temporarily programming off the WiCS-LV system), and during bi-ventricular pacing. Bi-ventricular capture will be demonstrated by comp | — |
Countries
Netherlands
Outcome results
None listed