cardiac arrest heart rhythm disorders
Conditions
Interventions
None listed
Sponsors
ELA Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines1 (Appendix L) or ESC guidelines35 (Appendix M) or any relevant currently-approved local guidelines for the implantation of an ICD-system 2. Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF)
Exclusion criteria
Exclusion criteria: 1. Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing. 2. Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 (Appendix L) or ESC35 (Appendix M) guidelines for the implantation of a CRT system. 3. Any contraindication for ICD therapy and the implant of a dual chamber ICD. 4. ICD replacement 5. Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month. 6. A PR interval > 250 ms or AR interval > 300 ms measured at implant. 7. Hypertrophic obstructive cardiomyopathy. 8. Acute myocarditis. 9. Unstable coronary symptoms or myocardial infarction within the last month. 10. Recent (within the last month) or planned cardiac revascularization or coronary angioplasty. 11. recently performed (in the last month) or planned cardiac surgery 12. Already included in another clinical study. 13. Life expectancy less than 24 months. 14. Inability to understand the purpose of the study or refusal to cooperate. 15. Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization. 16. Unavailability for scheduled follow-up at the implanting or cooperating center. 17. Age of less than 18 years. 18. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the clinical outcome of dual-chamber ICD therapy with minimized ventricular pacing compared with single-chamber device therapy with settings which are common in clinical practice. The outcome measure is the number of inappropriate shock therapy and a combined end point of all-cause mortality, hospitalisation for specified cardiac reasons (CHF, symptomatic AF, cardioversions for AF*, stroke, under-detected VT) and. Refer to 3.2.1 paragraph for more details. It is hypothesized that rate for unwanted clinical events is lower in the dual-chamber group than in the single-chamber group. In detail: the number of inappropriate shock therapies is lower in the dual-chamber arm but the rate of all cause mortality, hospitalisation for cardiac reasons as specified above is equal for both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. all cause mortality and cardio-vascular related mortality 2. Report Hospitalizations due to cardio-vascular event (specified for each type of event) 3. Report time to first occurrence of inappropriate ICD shock therapy 4. Evaluation of the impact of the different therapies on quality of life and heart failure status 5. Report sensitivity and specificity for the applied VT/SVT discrimination for the first 100 patients in each group who complete their 27 months follow up with a demonstrated correct pacing/sensing functioning 6. Report the inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes 7. Report the time to first documented occurrence of permanent or persistent AF* and number of patients moving into permanent AF 8. Report the cardiac dimensions obtained via echocardiography for a subset of patients of both study groups at baseline and after 27 months 9. Report Slow VT incidence 10. Report unscheduled visits and hospitalizations due to slow VT 11. Report system-related complications (see section 2.3.9 for definition) 12. Report the mean and median cumulative percentage of ventricular pacing for both study groups, and the % of pats with | — |
Countries
Netherlands
Outcome results
None listed