Reduced Left Ventricular Ejection Fraction
Conditions
Interventions
Patients identified as per the guidelines will receive an ICD.
Sponsors
Sorin Group Nederland NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Criteria for prophylactic ICD according to guidelines in patients with reduced LVEF - Written informed consent - Scheduled for implant of a PARADYM 8550 or PARADYM 9550
Exclusion criteria
Exclusion criteria: 1. Under the age of 18 years old 2. Presence of a permanent pacemaker or previous ICD 3. Permanent AF 4. NYHA IV 5. Within 8 weeks of infarction or within 3 months of coronary revascularization 6. Patient requiring permanent amiodarone or antiarrhythmic drugs. 7. Specific familial or genetic based arrhythmias. 8. ARVC, HCM, or severe valvular disease 9. CRT indication (European guidelines) 10. Renal hemodialysis 11. Recipient of cardiac transplant 12. Pregnancy 13. Advanced malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absence of arrhythmias requiring ICD intervention or the absence of sudden death | — |
Secondary
| Measure | Time frame |
|---|---|
| Demonstrate that heart failure hospital admission / cardiac death can be predicted by non invasive methods in patients with a reduced LVEF currently qualifying for primary ICD implantation. Show that slow VT as recorded by the ICD is associated with heart failure development/ cardiac death Show that safeR is not associated with ventricular pacing during follow-up Prospectively demonstrate that very low LVEF values (30% and less) are predictive for future ICD intervention in patients currently qualifying for primary ICD implantation with contemporary infarction and heart failure therapy. | — |
Countries
Netherlands
Outcome results
None listed