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

Completed

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

• Registration Number: NCT02064192
• Lead Sponsor: University Medical Center Goettingen

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.

Study Timeline

• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-17
• Study Start: 2014-05
• Primary Completion: 2019-05
• Study Completion: 2019-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2285

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First Appropriate ICD Shock	one to five years	Co-Primary Endpoint
All-Cause Mortality	one to five years	Co-Primary Endpoint

Secondary Outcome Measures

Name	Time	Method
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	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)
Any ICD Shock	one to five years	any ICD shock (appropriate or inappropriate)
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
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
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

Trial Locations

Locations (42)

KU Leuven, Div. of Cardiology; 🇧🇪 Leuven, Belgium

National Heart Hospital, Dept. of Cardiology; 🇧🇬 Sofia, Bulgaria

Klinički bolnički centar Rijeka, Div. of Cardiology; 🇭🇷 Rijeka, Croatia

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 Sestre milosrdnice, Div. of Cardiology; 🇭🇷 Zagreb, Croatia

Klinički bolnički centar Split, Div. of Cardiology; 🇭🇷 Split, Croatia

Opća Bolnica Zadar, Div. of Cardiology; 🇭🇷 Zadar, Croatia

Charitè Virchow Klinikum (CVK), Div. of Cardiology; 🇩🇪 Berlin, Germany

University Hospital Regensburg, Div. of Cardiology; 🇩🇪 Regensburg, Germany

Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology; 🇳🇱 Utrecht, Netherlands

Cardinal Stefan Wyszynski Institute of Cardiology (IKARD); 🇵🇱 Warszawa, Poland

Slovak Medical University, Heart Center; 🇸🇰 Bratislava, Slovakia

Masaryk University Hospital Brno, Div. of Cardiology; 🇨🇿 Brno, Czechia

Rigshospitalet, Div. of Cardiology; 🇩🇰 Copenhagen, Denmark

Palacky University Hospital Olomouc, Div. of Cardiology; 🇨🇿 Olomouc, Czechia

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

St. Marien-Hospital, Div. of Cardiology; 🇩🇪 Bonn, Germany

Klinikum Ludwigsburg, Div. of Cardiology; 🇩🇪 Ludwigsburg, Germany

Vivantes Humboldt Klinikum, Div. of Cardiology; 🇩🇪 Berlin, Germany

Klinikum Reinkenheide, Div. of Cardiology; 🇩🇪 Bremerhaven, Germany

Asklepios Klinikum Barmbek, Div. of Cardiology; 🇩🇪 Hamburg, Germany

University Medical Center, Div. of Cardiology; 🇩🇪 Göttingen, Germany

Herz im Zentrum; 🇩🇪 Hannover, Germany

Attikon University Hospital, Div. of Cardiology; 🇬🇷 Athens, Greece

Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München; 🇩🇪 Munich, Germany

Ludwig-Maximilians-University, Div. of Cardiology; 🇩🇪 Munich, Germany

Klinikum Weiden, Div. of Cardiology; 🇩🇪 Weiden, Germany

Karolinska Institute, Div. of Cardiology; 🇸🇪 Stockholm, Sweden

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

University Hospital Tuebingen, Div. of Cardiology; 🇩🇪 Tuebingen, Germany

Heliodor Swiecicki University Hospital, Div. of Cardiology; 🇵🇱 Poznan, Poland

Stredoslovenský ústav srdcových a cievnych chorôb (SUSSCH); 🇸🇰 Banska Bystrica, Slovakia

Medical University of Lodz; 🇵🇱 Lodz, Poland

Skane University Hospital, Div. of Cardiology; 🇸🇪 Lund, Sweden

University Hospital Basel, Div. of Cardiology; 🇨🇭 Basel, Switzerland

Hospital Clínic, Universitat de Barcelona; 🇪🇸 Barcelona, Spain

St. Paul's Cardiac Electrophysiology; 🇬🇧 London, Purley, Surrey, United Kingdom