Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe (EU-CERT-ICD)

University Medical Center Goettingen

Status: Completed

Conditions: Coronary Artery Disease; Implantable Defibrillator User; Myocardial Infarction; Dilated Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02064192

EU 602299

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,285 participants in 2 patient groups

ICD Group (n=1500)

Description:

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)

Description:

Patients who fulfill inclusion criteria but do not receive an ICD device will be followed as part of the Control Group