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

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ClinicalTrials.gov Identifier: NCT02064192
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
Markus Zabel, University Medical Center Goettingen

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
Coronary Artery Disease Myocardial Infarction Dilated Cardiomyopathy Implantable Defibrillator User

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.

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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 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : November 2019

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

Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: one to five years ]
    Co-Primary Endpoint

  2. First Appropriate ICD Shock [ Time Frame: one to five years ]
    Co-Primary Endpoint

Secondary Outcome Measures :
  1. Time to First Inappropriate Shock [ Time Frame: one to five years ]
  2. Sudden Cardiac Death [ Time Frame: one to five years ]
  3. Cardiac Death [ Time Frame: one to five years ]
  4. Non-Cardiac Death [ Time Frame: one to five years ]
  5. Arrhythmogenic Syncope [ Time Frame: one to five years ]
    presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee)

  6. Resuscitation [ Time Frame: one to five years ]
    successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group)

  7. Any ICD Shock [ Time Frame: one to five years ]
    any ICD shock (appropriate or inappropriate)

  8. Atrial Fibrillation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

Biospecimen Retention:   Samples With DNA
Whole blood sample for genetic analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064192

Show Show 42 study locations
Sponsors and Collaborators
University Medical Center Goettingen
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Principal Investigator: Markus Zabel, MD University Medical Center Goettingen
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Markus Zabel, Associate Professor of Medicine, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT02064192    
Other Study ID Numbers: EU 602299
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Markus Zabel, University Medical Center Goettingen:
defibrillator, implantable cardioverter
sudden cardiac death
primary prophylaxis
risk stratification
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Cardiomyopathy, Dilated
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Genetic Diseases, Inborn