Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

Terminated

• Conditions: Non-ischaemic Cardiomyopathy; Ischaemic Cardiomyopathy

• Registration Number: NCT01823211
• Lead Sponsor: University Hospital Ostrava

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 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-28
• Study First Posted: 2013-04-04
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ventricular tachyarrhytmia	36 months	ventricular tachycardia equal or \> 250/min,ventricular fibrillation, arrhythmic storm

Secondary Outcome Measures

Name	Time	Method
sudden cardiac death	36-months	death in 24-hours after symptom onset

Trial Locations

Locations (3)

University Hospital Olomouc; 🇨🇿 Olomouc, Czech Republic

Brno University Hospital; 🇨🇿 Brno, Czech Republic

University Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic