Holter (for) Risk Recognition & Conversion (of) life-threatening events (into survival)
Completed
- Conditions
- Reduced Left Ventricular Ejection Fractionreduced heart function10007521
- Registration Number
- NL-OMON56823
- Lead Sponsor
- Sorin Group Nederland NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 195
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method