Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy
Conditions
Interventions
Pre-implant visit
•Physical exam
•Cardiac medications
•Chest X-ray
•EKG*s
•Global assessment
•NYHA functional class
•Echocardiogram
•Blood specimens (serum creatinine, electrolytes, BUN, platelet coun
Sponsors
EBR Systems Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In this study, patients providing informed consent will be enrolled responding to the following criteria:;Patients with standard indications for CRT based upon the most recent ESC/EHRA 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*;Previously implanted or newly implanted CRT*s, pacemakers and ICD devices must provides dual-chamber pacing (RA and RV) if the patient has sinus rhythm, single-chamber pacing (RV) if the patient is in permanent AF
Exclusion criteria
Exclusion criteria: Study patients responding to the following criteria are excluded from participation: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study objectives: Safety Safety of the device has been defined as - Device-related complications (24 hour peri-operative and one month) - Procedure -related complications (24 hour peri-operative and one month) Performance Performance of the device has been defined as: - Bi-ventricular pacing capture (documented on 12 lead EKG at one month) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study objectives: Safety 1.Device-related complications up to 6 months 2. Major complications up to 6 months 3. Surveillance evaluation annually for 5 years Performance 1. Left ventricular pacing capture (documented on 12 lead EKG at one, 3 and 6 months) 2. Bi-ventricular pacing capture (documented on 12 lead EKG at 3 and 6 months) 3. Bi-ventricular pacing on 24 hour ambulatory monitoring at 1, 3, and 6 month Preliminary efficacy 1. Clinical composite score (all cause mortality, HF hospitalization, NYHA class, and patient global assessment (16)) at 6 months 2. Change in echocardiographic left ventricular end-systolic volume, left ventricular end-diastolic volume, and ejection fraction at 6 months 3. Change in blood laboratory Brain Natriuretic Peptide (NT-proBNP) at 6 months | — |
Countries
Netherlands
Outcome results
None listed