Clinical trial NCT02064192: Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
Official title: Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Infarction
Dilated Cardiomyopathy
Implantable Defibrillator User
Keywords: defibrillator, implantable cardioverter
sudden cardiac death
primary prophylaxis
risk stratification
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 2285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are eligible for primary prophylactic ICD implantation and potentially eligible for study participation will be identified based on echocardiographic and/or 12 lead ECG results. For ICD Group patients, screening will be shortly before scheduled ICD implantation. For Control Group patients, the time span between primary diagnosis of eligibility for primary ICD implantation and the date of the primary diagnosis of cardiomyopathy must be recorded in the eCRF, together with how and when the decision not to prescribe a defibrillator was reached. Control group will be recruited from patients with ischemic or dilated cardiomyopathies and LVEF ≤ 35%. Patients scheduled for ICD implantation (ICD Group) undergo screening and baseline assessments prior to ICD implantation. Patients for the Control Group will undergo baseline assessments as soon as possible after screening. Baseline assessments are identical for the ICD Group and the Control Group.

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.

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

Primary outcomes:
measure: All-Cause Mortality
timeFrame: one to five years
measure: First Appropriate ICD Shock
timeFrame: one to five years
Secondary outcomes:
measure: Time to First Inappropriate Shock
timeFrame: one to five years
measure: Sudden Cardiac Death
timeFrame: one to five years
measure: Cardiac Death
timeFrame: one to five years
measure: Non-Cardiac Death
timeFrame: one to five years
measure: Arrhythmogenic Syncope
timeFrame: one to five years
measure: Resuscitation
timeFrame: one to five years
measure: Any ICD Shock
timeFrame: one to five years
measure: Atrial Fibrillation
timeFrame: one to five years
measure: Quality of Life
timeFrame: one to five years
measure: Device Revision / Device Replacement
timeFrame: one to five years
measure: Costs and Cost-Effectiveness
timeFrame: one to five years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, Div. of Cardiology
city: Sofia
country: Bulgaria
facility: National Heart Hospital, Dept. of Cardiology
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital, Div. of Cardiology
city: Sofia
country: Bulgaria
facility: St. Ekaterina Hospital, Div. of Cardiology
city: Sofia
country: Bulgaria
facility: St. Anna University Hospital for Active Treatment, Div. of Cardiology
city: Krapinske Toplice
country: Croatia
facility: Magdalena Clinic
city: Rijeka
country: Croatia
facility: Klinički bolnički centar Rijeka, Div. of Cardiology
city: Split
country: Croatia
facility: Klinički bolnički centar Split, Div. of Cardiology
city: Zadar
country: Croatia
facility: Opća Bolnica Zadar, Div. of Cardiology
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Sestre milosrdnice, Div. of Cardiology
city: Brno
country: Czechia
facility: Masaryk University Hospital Brno, Div. of Cardiology
city: Olomouc
country: Czechia
facility: Palacky University Hospital Olomouc, Div. of Cardiology
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Div. of Cardiology
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Div. of Cardiology
city: Oulu
country: Finland
facility: Department of Internal Medicine, University of Oulu
city: Berlin
country: Germany
facility: CharitéCentrum 1 Health and Human Sciences, Institute for Social Medicine, Epidemiology and Health Economics
city: Berlin
country: Germany
facility: Charitè Virchow Klinikum (CVK), Div. of Cardiology
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum, Div. of Cardiology
city: Bonn
country: Germany
facility: St. Marien-Hospital, Div. of Cardiology
city: Bremerhaven
country: Germany
facility: Klinikum Reinkenheide, Div. of Cardiology
city: Göttingen
country: Germany
facility: University Medical Center, Div. of Cardiology
city: Hamburg
country: Germany
facility: Asklepios Klinikum Barmbek, Div. of Cardiology
city: Hannover
country: Germany
facility: Herz im Zentrum
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg, Div. of Cardiology
city: Munich
country: Germany
facility: Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München
city: Munich
country: Germany
facility: Ludwig-Maximilians-University, Div. of Cardiology
city: Regensburg
country: Germany
facility: University Hospital Regensburg, Div. of Cardiology
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Div. of Cardiology
city: Weiden
country: Germany
facility: Klinikum Weiden, Div. of Cardiology
city: Athens
country: Greece
facility: Attikon University Hospital, Div. of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology
city: Lodz
country: Poland
facility: Medical University of Lodz
city: Poznan
country: Poland
facility: Heliodor Swiecicki University Hospital, Div. of Cardiology
city: Warszawa
country: Poland
facility: Cardinal Stefan Wyszynski Institute of Cardiology (IKARD)
city: Banska Bystrica
country: Slovakia
facility: Stredoslovenský ústav srdcových a cievnych chorôb (SUSSCH)
city: Bratislava
country: Slovakia
facility: Slovak Medical University, Heart Center
city: Barcelona
country: Spain
facility: Hospital Clínic, Universitat de Barcelona
city: Lund
country: Sweden
facility: Skane University Hospital, Div. of Cardiology
city: Stockholm
country: Sweden
facility: Karolinska Institute, Div. of Cardiology
city: Basel
country: Switzerland
facility: University Hospital Basel, Div. of Cardiology
city: London
country: United Kingdom
facility: St. Paul's Cardiac Electrophysiology
state: Purley, Surrey
Study officials:
affiliation: University Medical Center Goettingen
name: Markus Zabel, MD
role: PRINCIPAL_INVESTIGATOR
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