Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005932

Trial Description

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Title

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

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Trial Acronym

EU-CERT-ICD

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00005932
  •   2014/07/11
  •   2014/02/13
  •   yes
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Secondary IDs

  •   NCT02064192  (ClinicalTrials.gov)
  •   EU 602299  (University Medical Center Goettingen)
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Health Condition or Problem studied

  •   Coronary Artery Disease
  •   Myocardial Infarction
  •   Dilated Cardiomyopathy
  •   Implantable Defibrillator User
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- All-Cause Mortality; time frame: one to four years; Co-Primary Endpoint
- First Appropriate ICD Shock; time frame: one to four years; Co-Primary Endpoint

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Secondary Outcome

- Time to First Inappropriate Shock; time frame: one to four years
- Sudden Cardiac Death; time frame: one to four years
- Cardiac Death; time frame: one to four years
- Non-Cardiac Death; time frame: one to four years
- Arrhythmogenic Syncope; time frame: one to four years; presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee)
- Resuscitation; time frame: one to four years; successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group)
- Any ICD Shock; time frame: one to four years; any ICD shock (appropriate or inappropriate)
- Atrial Fibrillation; time frame: one to four 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
- Quality of Life; time frame: one to four years; 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; 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; 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

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Countries of Recruitment

  •   Belgium
  •   Croatia
  •   Denmark
  •   Finland
  •   Germany
  •   Greece
  •   Hungary
  •   Netherlands
  •   Poland
  •   Slovakia
  •   Spain
  •   Sweden
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/05/31
  •   2500
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • University Medical Center Goettingen
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    • University Medical Center Goettingen
    • Markus Zabel, MD 
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    • Leonard Bergau, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   EU-CERT-ICD Website
  •   Hlatky MA, Douglas PS, Cook NL, Wells B, Benjamin EJ, Dickersin K, Goff DC, Hirsch AT, Hylek EM, Peterson ED, Roger VL, Selby JV, Udelson JE, Lauer MS. Future directions for cardiovascular disease comparative effectiveness research: report of a workshop sponsored by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol. 2012 Aug 14;60(7):569-80. doi: 10.1016/j.jacc.2011.12.057. Epub 2012 Jul 11.; 22796257
  •   Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. Review. No abstract available.; 11794197
  •   Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37.; 15659722
  •   Koller MT, Schaer B, Wolbers M, Sticherling C, Bucher HC, Osswald S. Death without prior appropriate implantable cardioverter-defibrillator therapy: a competing risk study. Circulation. 2008 Apr 15;117(15):1918-26. Epub 2008 Apr 7.; 18391108
  •   Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death. J Am Coll Cardiol. 2008 Sep 30;52(14):1111-21. doi: 10.1016/j.jacc.2008.05.058. Review.; 18804736
  •   Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.; 23131066
  •   MacFadden DR, Crystal E, Krahn AD, Mangat I, Healey JS, Dorian P, Birnie D, Simpson CS, Khaykin Y, Pinter A, Nanthakumar K, Calzavara AJ, Austin PC, Tu JV, Lee DS. Sex differences in implantable cardioverter-defibrillator outcomes: findings from a prospective defibrillator database. Ann Intern Med. 2012 Feb 7;156(3):195-203. doi: 10.7326/0003-4819-156-3-201202070-00007.; 22312139
  •   Cowie MR, Marshall D, Drummond M, Ferko N, Maschio M, Ekman M, de Roy L, Heidbuchel H, Verboven Y, Braunschweig F, Linde C, Boriani G. Lifetime cost-effectiveness of prophylactic implantation of a cardioverter defibrillator in patients with reduced left ventricular systolic function: results of Markov modelling in a European population. Europace. 2009 Jun;11(6):716-26. doi: 10.1093/europace/eup068. Epub 2009 Apr 9.; 19359333
  •   Kramer DB, Friedman PA, Kallinen LM, Morrison TB, Crusan DJ, Hodge DO, Reynolds MR, Hauser RG. Development and validation of a risk score to predict early mortality in recipients of implantable cardioverter-defibrillators. Heart Rhythm. 2012 Jan;9(1):42-6. doi: 10.1016/j.hrthm.2011.08.031. Epub 2011 Sep 3.; 21893137
  •   Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, Anstrom KJ, Curtis J, Al-Khalidi H, Curtis LH, Heidenreich P, Peterson ED, Sanders G, Clapp-Channing N, Lee KL, Moss AJ. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. 2013 Jan 2;309(1):55-62. doi: 10.1001/jama.2012.157182.; 23280225
  •   Schmidt G, Malik M, Barthel P, Schneider R, Ulm K, Rolnitzky L, Camm AJ, Bigger JT Jr, Schomig A. Heart-rate turbulence after ventricular premature beats as a predictor of mortality after acute myocardial infarction. Lancet. 1999 Apr 24;353(9162):1390-6.; 10227219
  •   Bauer A, Kantelhardt JW, Barthel P, Schneider R, Mäkikallio T, Ulm K, Hnatkova K, Schömig A, Huikuri H, Bunde A, Malik M, Schmidt G. Deceleration capacity of heart rate as a predictor of mortality after myocardial infarction: cohort study. Lancet. 2006 May 20;367(9523):1674-81.; 16714188
  •   Zabel M, Malik M, Hnatkova K, Papademetriou V, Pittaras A, Fletcher RD, Franz MR. Analysis of T-wave morphology from the 12-lead electrocardiogram for prediction of long-term prognosis in male US veterans. Circulation. 2002 Mar 5;105(9):1066-70.; 11877356
  •   Thomsen MB, Volders PG, Beekman JD, Matz J, Vos MA. Beat-to-Beat variability of repolarization determines proarrhythmic outcome in dogs susceptible to drug-induced torsades de pointes. J Am Coll Cardiol. 2006 Sep 19;48(6):1268-76. Epub 2006 Aug 28.; 16979017
  •   Exner DV, Kavanagh KM, Slawnych MP, Mitchell LB, Ramadan D, Aggarwal SG, Noullett C, Van Schaik A, Mitchell RT, Shibata MA, Gulamhussein S, McMeekin J, Tymchak W, Schnell G, Gillis AM, Sheldon RS, Fick GH, Duff HJ; REFINE Investigators. Noninvasive risk assessment early after a myocardial infarction the REFINE study. J Am Coll Cardiol. 2007 Dec 11;50(24):2275-84. Epub 2007 Nov 26.; 18068035
  •   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.; 22544366
  •   Buxton AE. Implantable cardioverter-defibrillators for primary prevention of sudden death: the quest to identify patients most likely to benefit. J Am Coll Cardiol. 2012 Oct 23;60(17):1656-8. doi: 10.1016/j.jacc.2012.06.041. Epub 2012 Sep 26.; 23021332
  •   Seegers J, Vos MA, Flevari P, Willems R, Sohns C, Vollmann D, Lüthje L, Kremastinos DT, Floré V, Meine M, Tuinenburg A, Myles RC, Simon D, Brockmöller J, Friede T, Hasenfuß G, Lehnart SE, Zabel M; EUTrigTreat Clinical Study Investigators. Rationale, objectives, and design of the EUTrigTreat clinical study: a prospective observational study for arrhythmia risk stratification and assessment of interrelationships among repolarization markers and genotype. Europace. 2012 Mar;14(3):416-22. doi: 10.1093/europace/eur352. Epub 2011 Nov 23.; 22117037
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  •   2
  •   2014/11/27
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