Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

Study Overview
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Brief Summary
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The EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.

Detailed Description
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The prospective study part is an observational, prospective multi-centre study which aims to enrol 2500 patients with ischemic or dilated cardiomyopathy and primary prophylactic ICD indication for reduced left ventricular ejection fraction (LVEF) according to current guidelines. According to the treating physician's decision and preference which is independent from study participation, patients are recruited into one of two groups: patients directly prior to first ICD implantation (ICD Group), or patients who are not considered for prophylactic ICD treatment by the physician or are considered but refuse ICD treatment (Control Group). Patients will undergo simple 12-lead electrocardiogram (ECG) and Holter ECG diagnostics at baseline as well as genetic biobanking at entry to the study. All patients will be subsequently followed for at least 1 year and up to 4 years. Co-primary endpoints are all-cause mortality and appropriate ICD shocks.

Official Title
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Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

Conditions
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Implantable Defibrillator User, Coronary Artery Disease, Myocardial Infarction, Dilated Cardiomyopathy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or dilated cardiomyopathy and recommendation for primary prophylactic ICD treatment following current international treatment guidelines Written informed consent If ICD implantation is planned, enrollment and study baseline testing needs to be completed before de-novo ICD implantation Exclusion Criteria: Permanent atrial fibrillation or atrial fibrillation at baseline in case more than 15% of such patients at a given time have been enrolled Indication for secondary prophylactic ICD treatment Indication or candidate for cardiac resynchronization therapy AV block II°-III° at resting heart rates Implanted pacemaker Unstable cardiac disease such as decompensated heart failure (NYHA functional class IV) or acute coronary syndrome Participation in other clinical trials which exclude enrolment in other trials

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| ICD Group (n=1500)<br>First ICD device implantation (after baseline assessments) is not part of this observational study and is carried out in the responsibility of the treating physician, all ICD-devices will undergo unique standard programming to ensure comparability of ICD shock events between patients. | |
| Control Group (n=750)<br>Patients who fulfill inclusion criteria but do not receive an ICD device will be followed as part of the Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | Co-Primary Endpoint | one to five years | 
| First Appropriate ICD Shock | Co-Primary Endpoint | one to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Inappropriate Shock |  | one to five years | 
| Sudden Cardiac Death |  | one to five years | 
| Cardiac Death |  | one to five years | 
| Non-Cardiac Death |  | one to five years | 
| Arrhythmogenic Syncope | presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee) | one to five years | 
| Resuscitation | successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group) | one to five years | 
| Any ICD Shock | any ICD shock (appropriate or inappropriate) | one to five years | 
| Atrial Fibrillation | atrial fibrillation (if documented), defined as an atrial tachyarrhythmia >250 beats per minute (bpm) lasting at least 30 seconds is considered as secondary endpoint | one to five years | 
| Quality of Life | Quality of life (QoL) will be assessed using the questionnaires SF 36, MacNew and Florida Patient Acceptance Survey | one to five years | 
| Device Revision / Device Replacement | the secondary endpoint Device Revision/Replacement will be recorded as electrode dislocation/revision, device revision for pocket hematoma, perforation, or infection, device exchange due to malfunction, battery exhaustion, other reason, or upgrade to dual chamber or CRT-D | one to five years | 
| Costs and Cost-Effectiveness | the secondary endpoint Costs will be assessed using patient questionnaires to the German-speaking study sites, an extension to other participating countries will be decided during the study, the assessment of cost-effectiveness will be realised by comparing cost-results with regard to changes in QoL | one to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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defibrillator, implantable cardioverter, sudden cardiac death, primary prophylaxis, risk stratification