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

Sponsor
University Medical Center Goettingen (Other)
Overall Status
Completed
CT.gov ID
NCT02064192
Collaborator
(none)
2,285
Enrollment
42
Locations
66
Actual Duration (Months)
54.4
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    2285 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
    Actual Study Start Date :
    May 1, 2014
    Actual Primary Completion Date :
    May 1, 2019
    Actual Study Completion Date :
    Nov 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.
    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

    Outcome Measures

    Primary Outcome Measures

    1. All-Cause Mortality [one to five years]

      Co-Primary Endpoint

    2. First Appropriate ICD Shock [one to five years]

      Co-Primary Endpoint

    Secondary Outcome Measures

    1. Time to First Inappropriate Shock [one to five years]

    2. Sudden Cardiac Death [one to five years]

    3. Cardiac Death [one to five years]

    4. Non-Cardiac Death [one to five years]

    5. Arrhythmogenic Syncope [one to five years]

      presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee)

    6. Resuscitation [one to five years]

      successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group)

    7. Any ICD Shock [one to five years]

      any ICD shock (appropriate or inappropriate)

    8. 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

    9. 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

    10. 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

    11. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    1. or acute coronary syndrome
    • Participation in other clinical trials which exclude enrolment in other trials

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KU Leuven, Div. of Cardiology Leuven Belgium
    2 National Heart Hospital, Dept. of Cardiology Sofia Bulgaria 1309
    3 Acibadem City Clinic Tokuda Hospital, Div. of Cardiology Sofia Bulgaria 1407
    4 St. Ekaterina Hospital, Div. of Cardiology Sofia Bulgaria 1431
    5 St. Anna University Hospital for Active Treatment, Div. of Cardiology Sofia Bulgaria 1709
    6 Magdalena Clinic Krapinske Toplice Croatia 49217
    7 Klinički bolnički centar Rijeka, Div. of Cardiology Rijeka Croatia 51000
    8 Klinički bolnički centar Split, Div. of Cardiology Split Croatia 21000
    9 Opća Bolnica Zadar, Div. of Cardiology Zadar Croatia 23000
    10 Klinički bolnički centar Sestre milosrdnice, Div. of Cardiology Zagreb Croatia 10000
    11 Masaryk University Hospital Brno, Div. of Cardiology Brno Czechia 62500
    12 Palacky University Hospital Olomouc, Div. of Cardiology Olomouc Czechia 77147
    13 Rigshospitalet, Div. of Cardiology Copenhagen Denmark 2100
    14 Gentofte Hospital, Div. of Cardiology Hellerup Denmark 2900
    15 Department of Internal Medicine, University of Oulu Oulu Finland 90014
    16 CharitéCentrum 1 Health and Human Sciences, Institute for Social Medicine, Epidemiology and Health Economics Berlin Germany 10117
    17 Charitè Virchow Klinikum (CVK), Div. of Cardiology Berlin Germany 13353
    18 Vivantes Humboldt Klinikum, Div. of Cardiology Berlin Germany 13509
    19 St. Marien-Hospital, Div. of Cardiology Bonn Germany 53115
    20 Klinikum Reinkenheide, Div. of Cardiology Bremerhaven Germany 27574
    21 University Medical Center, Div. of Cardiology Göttingen Germany 37075
    22 Asklepios Klinikum Barmbek, Div. of Cardiology Hamburg Germany 22307
    23 Herz im Zentrum Hannover Germany 30159
    24 Klinikum Ludwigsburg, Div. of Cardiology Ludwigsburg Germany 71640
    25 Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München Munich Germany 80636
    26 Ludwig-Maximilians-University, Div. of Cardiology Munich Germany 81377
    27 University Hospital Regensburg, Div. of Cardiology Regensburg Germany 93053
    28 University Hospital Tuebingen, Div. of Cardiology Tuebingen Germany 72076
    29 Klinikum Weiden, Div. of Cardiology Weiden Germany 92637
    30 Attikon University Hospital, Div. of Cardiology Athens Greece
    31 Semmelweis University Heart and Vascular Center Budapest Hungary 1122
    32 Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology Utrecht Netherlands 3584
    33 Medical University of Lodz Lodz Poland
    34 Heliodor Swiecicki University Hospital, Div. of Cardiology Poznan Poland 60355
    35 Cardinal Stefan Wyszynski Institute of Cardiology (IKARD) Warszawa Poland 04628
    36 Stredoslovenský ústav srdcových a cievnych chorôb (SUSSCH) Banska Bystrica Slovakia 97401
    37 Slovak Medical University, Heart Center Bratislava Slovakia
    38 Hospital Clínic, Universitat de Barcelona Barcelona Spain 08036
    39 Skane University Hospital, Div. of Cardiology Lund Sweden 22241
    40 Karolinska Institute, Div. of Cardiology Stockholm Sweden 17176
    41 University Hospital Basel, Div. of Cardiology Basel Switzerland 4031
    42 St. Paul's Cardiac Electrophysiology London Purley, Surrey United Kingdom CR8 3NQ

    Sponsors and Collaborators

    • University Medical Center Goettingen

    Investigators

    • Principal Investigator: Markus Zabel, MD, University Medical Center Goettingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Markus Zabel, Associate Professor of Medicine, University Medical Center Goettingen
    ClinicalTrials.gov Identifier:
    NCT02064192
    Other Study ID Numbers:
    • EU 602299
    First Posted:
    Feb 17, 2014
    Last Update Posted:
    Mar 24, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Markus Zabel, Associate Professor of Medicine, University Medical Center Goettingen
    defibrillator, implantable cardioverter
    sudden cardiac death
    primary prophylaxis
    risk stratification
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Infarction
    Cardiomyopathies
    Cardiomyopathy, Dilated
    Infarction

    Study Results

    No Results Posted as of Mar 24, 2020