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Coronary Artery DiseaseEU-CERT-ICDNCT02064192

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

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University Medical Center Goettingen at 42 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,285 participants
Where
42 sitesin 16 countries
Study dates
May 2014to Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

42 sites in 16 countries.

42 sites in 16 countries

Germany14 sites

  • CharitéCentrum 1 Health and Human Sciences, Institute for Social Medicine, Epidemiology and Health Economics

    Berlin, 10117

  • Charitè Virchow Klinikum (CVK), Div. of Cardiology

    Berlin, 13353

  • Vivantes Humboldt Klinikum, Div. of Cardiology

    Berlin, 13509

  • St. Marien-Hospital, Div. of Cardiology

    Bonn, 53115

  • Klinikum Reinkenheide, Div. of Cardiology

    Bremerhaven, 27574

  • University Medical Center, Div. of Cardiology

    Göttingen, 37075

  • Asklepios Klinikum Barmbek, Div. of Cardiology

    Hamburg, 22307

  • Herz im Zentrum

    Hanover, 30159

  • Klinikum Ludwigsburg, Div. of Cardiology

    Ludwigsburg, 71640

  • Department of Cardiovascular Diseases, German Heart Centre Munich, Technische Universität München

    Munich, 80636

  • Ludwig-Maximilians-University, Div. of Cardiology

    Munich, 81377

  • University Hospital Regensburg, Div. of Cardiology

    Regensburg, 93053

  • University Hospital Tuebingen, Div. of Cardiology

    Tübingen, 72076

  • Klinikum Weiden, Div. of Cardiology

    Weiden, 92637

Other trials in Germany

Croatia5 sites

  • Magdalena Clinic

    Krapinske Toplice, 49217

  • Klinički bolnički centar Rijeka, Div. of Cardiology

    Rijeka, 51000

  • Klinički bolnički centar Split, Div. of Cardiology

    Split, 21000

  • Opća Bolnica Zadar, Div. of Cardiology

    Zadar, 23000

  • Klinički bolnički centar Sestre milosrdnice, Div. of Cardiology

    Zagreb, 10000

Other trials in Croatia

Bulgaria4 sites

  • National Heart Hospital, Dept. of Cardiology

    Sofia, 1309

  • Acibadem City Clinic Tokuda Hospital, Div. of Cardiology

    Sofia, 1407

  • St. Ekaterina Hospital, Div. of Cardiology

    Sofia, 1431

  • St. Anna University Hospital for Active Treatment, Div. of Cardiology

    Sofia, 1709

Other trials in Bulgaria

Poland3 sites

  • Medical University of Lodz

    Lodz

  • Heliodor Swiecicki University Hospital, Div. of Cardiology

    Poznan, 60355

  • Cardinal Stefan Wyszynski Institute of Cardiology (IKARD)

    Warsaw, 04628

Other trials in Poland

Czechia2 sites

  • Masaryk University Hospital Brno, Div. of Cardiology

    Brno, 62500

  • Palacky University Hospital Olomouc, Div. of Cardiology

    Olomouc, 77147

Other trials in Czechia

Denmark2 sites

  • Rigshospitalet, Div. of Cardiology

    Copenhagen, 2100

  • Gentofte Hospital, Div. of Cardiology

    Hellerup, 2900

Other trials in Denmark

Slovakia2 sites

  • Stredoslovenský ústav srdcových a cievnych chorôb (SUSSCH)

    Banská Bystrica, 97401

  • Slovak Medical University, Heart Center

    Bratislava

Other trials in Slovakia

Sweden2 sites

  • Skane University Hospital, Div. of Cardiology

    Lund, 22241

  • Karolinska Institute, Div. of Cardiology

    Stockholm, 17176

Other trials in Sweden

Belgium1 site

  • KU Leuven, Div. of Cardiology

    Leuven

Other trials in Belgium

Finland1 site

  • Department of Internal Medicine, University of Oulu

    Oulu, 90014

Other trials in Finland

Greece1 site

  • Attikon University Hospital, Div. of Cardiology

    Athens

Other trials in Greece

Hungary1 site

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122

Other trials in Hungary

Netherlands1 site

  • Universitair Medisch Centrum Utrecht, Dept. of Physiology & Cardiology

    Utrecht, 3584

Other trials in Netherlands

Spain1 site

  • Hospital Clínic, Universitat de Barcelona

    Barcelona, 08036

Other trials in Spain

Switzerland1 site

  • University Hospital Basel, Div. of Cardiology

    Basel, 4031

Other trials in Switzerland

United Kingdom1 site

  • St. Paul's Cardiac Electrophysiology

    London, Purley, Surrey, CR8 3NQ

Other trials in United Kingdom

About this study

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.

Read the 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.

Keywords
defibrillator, implantable cardioverter, sudden cardiac death, primary prophylaxis, risk stratification
Medical subject headings
Coronary Artery Disease, Myocardial Infarction, Cardiomyopathy, Dilated, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02064192
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Mortality

    Co-Primary Endpoint

    Measured: one to five years

  2. First Appropriate ICD Shock

    Co-Primary Endpoint

    Measured: one to five years

Secondary outcomes (11)

  1. Time to First Inappropriate Shock

    Measured: one to five years

  2. Sudden Cardiac Death

    Measured: one to five years

  3. Cardiac Death

    Measured: one to five years

  4. Non-Cardiac Death

    Measured: one to five years

  5. Arrhythmogenic Syncope

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

    Measured: one to five years

  6. Resuscitation

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

    Measured: one to five years

  7. Any ICD Shock

    any ICD shock (appropriate or inappropriate)

    Measured: one to five years

  8. Atrial Fibrillation

    atrial fibrillation (if documented), defined as an atrial tachyarrhythmia >250 beats per minute (bpm) lasting at least 30 seconds is considered as secondary endpoint

    Measured: one to five years

  9. Quality of Life

    Quality of life (QoL) will be assessed using the questionnaires SF 36, MacNew and Florida Patient Acceptance Survey

    Measured: one to five years

  10. Device Revision / Device Replacement

    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

    Measured: one to five years

  11. Costs and Cost-Effectiveness

    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

    Measured: one to five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionMay 2019
  4. Study completionNov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02064192
Sponsor's protocol ID
EU 602299
Acronym
EU-CERT-ICD
Status last verified
Mar 2020
First submitted
13 Feb 2014
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22796257

  • Huikuri HV, Castellanos A, Myerburg RJ. Sudden death due to cardiac arrhythmias. N Engl J Med. 2001 Nov 15;345(20):1473-82. doi: 10.1056/NEJMra000650. No abstract available.

    PubMed 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. doi: 10.1056/NEJMoa043399.

    PubMed 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. doi: 10.1161/CIRCULATIONAHA.107.742155. Epub 2008 Apr 7.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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. doi: 10.1016/S0140-6736(98)08428-1.

    PubMed 10227219

  • Bauer A, Kantelhardt JW, Barthel P, Schneider R, Makikallio T, Ulm K, Hnatkova K, Schomig 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. doi: 10.1016/S0140-6736(06)68735-7.

    PubMed 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. doi: 10.1161/hc0902.104598.

    PubMed 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. doi: 10.1016/j.jacc.2006.05.048. Epub 2006 Aug 28.

    PubMed 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. doi: 10.1016/j.jacc.2007.08.042. Epub 2007 Nov 26.

    PubMed 18068035

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Myocardial Infarction, run by University Medical Center Goettingen at 42 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Germany, Croatia, Bulgaria, Poland, Czechia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality (time frame: one to five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02064192, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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