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

March 23, 2020 updated by: Markus Zabel, University Medical Center Goettingen
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: one to five years
Co-Primary Endpoint
one to five years
First Appropriate ICD Shock
Time Frame: one to five years
Co-Primary Endpoint
one to five years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Inappropriate Shock
Time Frame: one to five years
one to five years
Sudden Cardiac Death
Time Frame: one to five years
one to five years
Cardiac Death
Time Frame: one to five years
one to five years
Non-Cardiac Death
Time Frame: one to five years
one to five years
Arrhythmogenic Syncope
Time Frame: one to five years
presumed arrhythmogenic syncopes (per the judgment of each investigator and the endpoint committee)
one to five years
Resuscitation
Time Frame: one to five years
successful resuscitation for ventricular tachyarrhythmias (especially in the non ICD Control Group)
one to five years
Any ICD Shock
Time Frame: one to five years
any ICD shock (appropriate or inappropriate)
one to five years
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
one to five years
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
one to five years
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
one to five years
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
one to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Center Goettingen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Markus Zabel, MD, University Medical Center Goettingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EU 602299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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