Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

Study Overview
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Brief Summary
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The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.

Detailed Description
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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.

Official Title
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Heart Rate Variability, Microvolt T-wave Alternans and Cardiac Magnetic Resonance Imaging Analysis in Primary Preventive ImplantablE Cardioverter-defibrillator Recipients Profitability Trial - HAPPIER Trial

Conditions
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Ischaemic Cardiomyopathy, Non-ischaemic Cardiomyopathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ischaemic cardiomyopathy<br>EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation | |
| non-ischaemic cardiomyopathy<br>EP study,magnetic resonance imaging with LGE, ICD implantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventricular tachyarrhytmia | ventricular tachycardia equal or > 250/min,ventricular fibrillation, arrhythmic storm | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sudden cardiac death | death in 24-hours after symptom onset | 36-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD (Implantable cardioverter-defibrillator), Heart rate variability, MTWA (Microvolt T-alternans), Magnetic resonance imaging (MRI)