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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University Medical Center Goettingen
Sponsor:
Information provided by (Responsible Party):
Markus Zabel, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT02064192
First received: February 13, 2014
Last updated: November 1, 2014
Last verified: November 2014
  Purpose

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
Coronary Artery Disease
Myocardial Infarction
Dilated Cardiomyopathy
Implantable Defibrillator User

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe

Resource links provided by NLM:


Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:
  • All-Cause Mortality [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    Co-Primary Endpoint

  • First Appropriate ICD Shock [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    Co-Primary Endpoint


Secondary Outcome Measures:
  • Time to First Inappropriate Shock [ Time Frame: one to four years ] [ Designated as safety issue: No ]
  • Sudden Cardiac Death [ Time Frame: one to four years ] [ Designated as safety issue: No ]
  • Cardiac Death [ Time Frame: one to four years ] [ Designated as safety issue: No ]
  • Non-Cardiac Death [ Time Frame: one to four years ] [ Designated as safety issue: No ]
  • Arrhythmogenic Syncope [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee)

  • Resuscitation [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group)

  • Any ICD Shock [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    any ICD shock (appropriate or inappropriate)

  • Atrial Fibrillation [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    atrial fibrillation (if documented), defined as an atrial tachyarrhythmia >250 beats per minute (bpm) lasting at least 30 seconds is considered as secondary endpoint

  • Quality of Life [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    quality of life (QoL) will be assessed using the questionnaires SF 36, MacNew and Florida Patient Acceptance Survey

  • Device Revision / Device Replacement [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    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

  • Costs and Cost-Effectiveness [ Time Frame: one to four years ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples With DNA

Whole blood sample for genetic analysis


Estimated Enrollment: 2500
Study Start Date: May 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064192

Contacts
Contact: Leonard Bergau, MD +49 551 3910265 leonard.bergau@med.uni-goettingen.de
Contact: Pascal Munoz, MD +49 551 399954 pascal.munoz@med.uni-goettingen.de

Locations
Belgium
KU Leuven, Div. of Cardiology Recruiting
Leuven, Belgium
Contact: Rik Willems, MD, PhD       rik.willems@med.kuleuven.be   
Principal Investigator: Rik Willems, MD, PhD         
Croatia
Magdalena Clinic Recruiting
Krapinske Toplice, Croatia, 49217
Contact: Robert Bernat, MD, PhD    +38 54 9244 115    robert.bernat@magdalena.hr   
Principal Investigator: Janko Szavits-Nossan, MD         
Denmark
Rigshospitalet, Div. of Cardiology Recruiting
Copenhagen, Denmark, 2100
Contact: Jesper Hastrup Svendsen, MD    +45 3545 2735    jesper.hastrup.svendsen@rh.regionh.dk   
Principal Investigator: Jesper Hastrup Svendsen, MD         
Finland
Department of Internal Medicine, University of Oulu Recruiting
Oulu, Finland, 90014
Contact: Heikki V Huikuri, MD    + 35 88 3154108    heikki.huikuri@oulu.fi   
Principal Investigator: Heikki V Huikuri, MD         
Germany
CharitéCentrum 1 Health and Human Sciences, Institute for Social Medicine, Epidemiology and Health Economics Active, not recruiting
Berlin, Germany, 10117
University Medical Center, Div. of Cardiology Recruiting
Goettingen, Germany, 37075
Contact: Markus Zabel, MD    +49 551 3910265    markus.zabel@med.uni-goettingen.de   
Sub-Investigator: Lars Luethje, MD         
Sub-Investigator: Pascal Munoz, MD         
Sub-Investigator: Leonard Bergau, MD         
Principal Investigator: Markus Zabel, MD         
Sub-Investigator: Christian Sohns, MD         
Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München Recruiting
Munich, Germany, 80636
Contact: Georg Schmidt, MD    +49 89 4140 2352    gschmidt@tum.de   
Principal Investigator: Georg Schmidt, MD         
Ludwig-Maximilians-University, Div. of Cardiology Recruiting
Munich, Germany, 81377
Contact: Stefan Kääb, MD    +49-89-7095-6159    stefan.kaab@med.uni-muenchen.de   
Principal Investigator: Stefan Kaab, MD         
Sub-Investigator: Moritz F Sinner, MD         
Principal Investigator: Axel Bauer, MD         
University Hospital Tuebingen, Div. of Cardiology Recruiting
Tuebingen, Germany, 72076
Contact: Christine S Zuern, MD       christine.zuern@med.uni-tuebingen.de   
Greece
Attikon University Hospital, Div. of Cardiology Recruiting
Athens, Greece
Contact: Panagiota Flevari, MD       pflevari@yahoo.com   
Principal Investigator: Panagiota Flevari, MD         
Hungary
Semmelweis University Heart and Vascular Center Recruiting
Budapest, Hungary, 1122
Contact: Béla Merkely, MD, PhD, DSc    +36 1 458 6810    merkely.bela@kardio.sote.hu   
Principal Investigator: Béla Merkely, MD, PhD, DSc         
Sub-Investigator: Gábor Széplaki, MD, PhD         
Netherlands
Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology Recruiting
Utrecht, Netherlands, 3584
Contact: Marc A Vos, PhD    +31 30 253 8900    m.a.vos@umcutrecht.nl   
Contact: Jeannette Visser-Bouman, RN    +31 88 7559433      
Principal Investigator: Marc A Vos, PhD         
Sub-Investigator: Anton E Tuinenburg, MD         
Poland
Medical University of Lodz Recruiting
Lodz, Poland
Contact: Andrzej Lubinski, MD       lubinski.a@gmail.com   
Principal Investigator: Andrzej Lubinski, MD         
Slovakia
Slovak Medical University, Heart Center Not yet recruiting
Bratislava, Slovakia
Contact: Robert Hatala, MD       robert.hatala@nusch.sk   
Principal Investigator: Robert Hatala, MD         
Spain
Hospital Clínic, Universitat de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Josep Brugada, MD       jbrugada@clinic.ub.es   
Principal Investigator: Josep Brugada, MD         
Sub-Investigator: Elena Arbelo, MD         
Sweden
Karolinska Institute, Div. of Cardiology Not yet recruiting
Stockholm, Sweden, 17176
Contact: Frieder Braunschweig, MD, PhD    +46-8-51771629    frieder.braunschweig@karolinska.se   
Principal Investigator: Frieder Braunschweig, MD, PhD         
Switzerland
University Hospital Basel, Div. of Cardiology Recruiting
Basel, Switzerland, 4031
Contact: Christian Sticherling, MD    +41-61-556 5817    csticherling@uhbs.ch   
Principal Investigator: Christian Sticherling, MD         
United Kingdom
St. Paul's Cardiac Electrophysiology Active, not recruiting
London, Purley, Surrey, United Kingdom, CR8 3NQ
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Principal Investigator: Markus Zabel, MD University Medical Center Goettingen
  More Information

Additional Information:
Publications:
Ellinor PT, Lunetta KL, Albert CM, Glazer NL, Ritchie MD, Smith AV, Arking DE, Müller-Nurasyid M, Krijthe BP, Lubitz SA, Bis JC, Chung MK, Dörr M, Ozaki K, Roberts JD, Smith JG, Pfeufer A, Sinner MF, Lohman K, Ding J, Smith NL, Smith JD, Rienstra M, Rice KM, Van Wagoner DR, Magnani JW, Wakili R, Clauss S, Rotter JI, Steinbeck G, Launer LJ, Davies RW, Borkovich M, Harris TB, Lin H, Völker U, Völzke H, Milan DJ, Hofman A, Boerwinkle E, Chen LY, Soliman EZ, Voight BF, Li G, Chakravarti A, Kubo M, Tedrow UB, Rose LM, Ridker PM, Conen D, Tsunoda T, Furukawa T, Sotoodehnia N, Xu S, Kamatani N, Levy D, Nakamura Y, Parvez B, Mahida S, Furie KL, Rosand J, Muhammad R, Psaty BM, Meitinger T, Perz S, Wichmann HE, Witteman JC, Kao WH, Kathiresan S, Roden DM, Uitterlinden AG, Rivadeneira F, McKnight B, Sjögren M, Newman AB, Liu Y, Gollob MH, Melander O, Tanaka T, Stricker BH, Felix SB, Alonso A, Darbar D, Barnard J, Chasman DI, Heckbert SR, Benjamin EJ, Gudnason V, Kääb S. Meta-analysis identifies six new susceptibility loci for atrial fibrillation. Nat Genet. 2012 Apr 29;44(6):670-5. doi: 10.1038/ng.2261.

Responsible Party: Markus Zabel, Associate Professor of Medicine, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT02064192     History of Changes
Other Study ID Numbers: EU 602299
Study First Received: February 13, 2014
Last Updated: November 1, 2014
Health Authority: Germany: Ethics Commission
All Other Countries: Ethics Commission

Keywords provided by University Medical Center Goettingen:
defibrillator, implantable cardioverter
sudden cardiac death
primary prophylaxis
risk stratification

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014