NL-OMON37942
Completed
Not Applicable
Arrhythmia Risk Stratification in a Clinical Patient Cohort and Correlation with Genotype and Environmental Modulators - EU-Trig Treat Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arrhythmia risk stratification
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 100
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Clinical indication (primary and secondary prevention of SCD) for ICD implantation/ICD exchange or chronically implanted ICD
- •\- Age \> 18 years
- •\- Written informed consent
- •\- Negative pregnancy test in women of childbearing potential
- •\- No participation in other clinical trials within one month before and after enrolment into the study;\- Cardiac resynchronisation therapy (CRT) devices are excluded from the study (for their special effects in reversal of repolarisation remodeling) for at least 6 months after implantation, thereafter single\- and dual\-chamber devices are still to be preferred. Single and dual\-chamber device exhange patients recruited to the invasive studies must not have RV pacing \> 20% of the time.
- •\- Up to 60% of all patients with coronary artery disease, with or without a history of myocardial infarction (occurrence of STEMI, NSTEMI and highest CKmax will be recorded). This will be monitored by Dr. Eva Müller from the clinical IFS institute in G\*ttingen.
- •\- Up to 350 patients with non\-ischemic cardiomyopathies (180 dilated cardiomyopathy \[DCM], 70 hypertrophic cardiomyopathy \[HCM] / hypertrophic obstructive cardiomyopathy \[HOCM], 20 arrhythmogenic right ventricular cardiomyopathy \[ARVC], channelopathies (30 Brugada syndrome, 20 long QT syndrome, 10 catecholaminergic polymorphic ventricular tachycardia \[CPVT]) or idiopathic VT/VF (n\=20\) with any LV ejection fraction. This will be monitored by Dr. Eva Müller from the clinical IFS institute in G\*ttingen.
Exclusion Criteria
- •\- Unstable cardiac disease such as decompensated heart failure (NYHA class IV) or acute coronary syndrome or symptomatic arrhythmias
- •\- Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery less than 3 months ago
- •\- ICDs unable to deliver programmed ventricular stimulation via programmer (in the chronic ICD group)
- •\- Permanent atrial fibrillation if more than 20% of all patients at a given time during the study are enrolled, this condition will be flagged by the study manager Dr. Eva Müller from the clinical IFS institute in G\*ttingen which also runs the secure clinical database.
Outcomes
Primary Outcomes
Not specified
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