Status:
TERMINATED
Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients
Lead Sponsor:
University Hospital Ostrava
Collaborating Sponsors:
University Hospital Olomouc
Brno University Hospital
Conditions:
Ischaemic Cardiomyopathy
Non-ischaemic Cardiomyopathy
Eligibility:
All Genders
18-90 years
Brief Summary
The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.
Detailed Description
Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately ...
Eligibility Criteria
Inclusion
- LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
- LVD d/t MI, LVEF 30% to 35%, NYHA II, III
- LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
- LVD d/t MI, LVEF 30% or less, NYHA I
- NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
- NICM, LVEF 30% to 35%, NYHA II, III
- NICM, LVEF 30% or less, NYHA I
- signed informed consent
Exclusion
- metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- severe claustrophobia may not be able to tolerate an MRI scan
- heart rhythm device in place before enrollment
- atrial fibrillation in time of enrollment
- ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
- NYHA or CCS class IV
- PCI or CABG in last 3 months
- CMP/TIA in last 3 months
- syncope of unknown etiology
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01823211
Start Date
March 1 2013
End Date
April 1 2016
Last Update
October 28 2016
Active Locations (3)
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1
Brno University Hospital
Brno, Czechia, 62500
2
University Hospital Olomouc
Olomouc, Czechia, 775 20
3
University Hospital Ostrava
Ostrava, Czechia, 70852