Coronary Artery Disease, Dilated Cardiomyopathy, Implantable Defibrillator User, Myocardial Infarction
Conditions
Keywords
defibrillator, implantable cardioverter, sudden cardiac death, primary prophylaxis, risk stratification
Brief summary
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
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.
Interventions
None listed
Sponsors
University Medical Center Goettingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | one to five years | Co-Primary Endpoint |
| First Appropriate ICD Shock | one to five years | Co-Primary Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | one to five years | — |
| Non-Cardiac Death | one to five years | — |
| Arrhythmogenic Syncope | one to five years | presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee) |
| Resuscitation | one to five years | successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group) |
| Time to First Inappropriate Shock | one to five years | — |
| Atrial Fibrillation | one to five years | atrial fibrillation (if documented), defined as an atrial tachyarrhythmia \>250 beats per minute (bpm) lasting at least 30 seconds is considered as secondary endpoint |
| Quality of Life | one to five years | Quality of life (QoL) will be assessed using the questionnaires SF 36, MacNew and Florida Patient Acceptance Survey |
| Device Revision / Device Replacement | one to five years | 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 |
| Costs and Cost-Effectiveness | one to five years | 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 |
| Any ICD Shock | one to five years | any ICD shock (appropriate or inappropriate) |
| Sudden Cardiac Death | one to five years | — |
Countries
Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, Germany, Greece, Hungary, Netherlands, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed