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

NCT ID: NCT02064192

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-11-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICD Group (n=1500)

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.

No interventions assigned to this group

Control Group (n=750)

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Markus Zabel

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Zabel, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Goettingen

Locations

KU Leuven, Div. of Cardiology

Leuven, , Belgium

National Heart Hospital, Dept. of Cardiology

Sofia, , Bulgaria

Acibadem City Clinic Tokuda Hospital, Div. of Cardiology

Sofia, , Bulgaria

St. Ekaterina Hospital, Div. of Cardiology

Sofia, , Bulgaria

St. Anna University Hospital for Active Treatment, Div. of Cardiology

Sofia, , Bulgaria

Magdalena Clinic

Krapinske Toplice, , Croatia

Klinički bolnički centar Rijeka, Div. of Cardiology

Rijeka, , Croatia

Klinički bolnički centar Split, Div. of Cardiology

Split, , Croatia

Opća Bolnica Zadar, Div. of Cardiology

Zadar, , Croatia

Klinički bolnički centar Sestre milosrdnice, Div. of Cardiology

Zagreb, , Croatia

Masaryk University Hospital Brno, Div. of Cardiology

Brno, , Czechia

Palacky University Hospital Olomouc, Div. of Cardiology

Olomouc, , Czechia

Rigshospitalet, Div. of Cardiology

Copenhagen, , Denmark

Gentofte Hospital, Div. of Cardiology

Hellerup, , Denmark

Department of Internal Medicine, University of Oulu

Oulu, , Finland

CharitéCentrum 1 Health and Human Sciences, Institute for Social Medicine, Epidemiology and Health Economics

Berlin, , Germany

Charitè Virchow Klinikum (CVK), Div. of Cardiology

Berlin, , Germany

Vivantes Humboldt Klinikum, Div. of Cardiology

Berlin, , Germany

St. Marien-Hospital, Div. of Cardiology

Bonn, , Germany

Klinikum Reinkenheide, Div. of Cardiology

Bremerhaven, , Germany

University Medical Center, Div. of Cardiology

Göttingen, , Germany

Asklepios Klinikum Barmbek, Div. of Cardiology

Hamburg, , Germany

Herz im Zentrum

Hanover, , Germany

Klinikum Ludwigsburg, Div. of Cardiology

Ludwigsburg, , Germany

Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München

Munich, , Germany

Ludwig-Maximilians-University, Div. of Cardiology

Munich, , Germany

University Hospital Regensburg, Div. of Cardiology

Regensburg, , Germany

University Hospital Tuebingen, Div. of Cardiology

Tübingen, , Germany

Klinikum Weiden, Div. of Cardiology

Weiden, , Germany

Attikon University Hospital, Div. of Cardiology

Athens, , Greece

Semmelweis University Heart and Vascular Center

Budapest, , Hungary

Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology

Utrecht, , Netherlands

Medical University of Lodz

Lodz, , Poland

Heliodor Swiecicki University Hospital, Div. of Cardiology

Poznan, , Poland

Cardinal Stefan Wyszynski Institute of Cardiology (IKARD)

Warsaw, , Poland

Stredoslovenský ústav srdcových a cievnych chorôb (SUSSCH)

Banská Bystrica, , Slovakia

Slovak Medical University, Heart Center

Bratislava, , Slovakia

Hospital Clínic, Universitat de Barcelona

Barcelona, , Spain

Skane University Hospital, Div. of Cardiology

Lund, , Sweden

Karolinska Institute, Div. of Cardiology

Stockholm, , Sweden

University Hospital Basel, Div. of Cardiology

Basel, , Switzerland

St. Paul's Cardiac Electrophysiology

London, Purley, Surrey, United Kingdom

Countries

Belgium; Bulgaria; Croatia; Czechia; Denmark; Finland; Germany; Greece; Hungary; Netherlands; Poland; Slovakia; Spain; Sweden; Switzerland; United Kingdom

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Related Links

http://www.eu-cert-icd.eu

EU-CERT-ICD Website

Other Identifiers

EU 602299

Identifier Type: -

Identifier Source: org_study_id