Brief Title
Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
Official Title
Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
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.
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
Observational
Primary Outcome
All-Cause Mortality
Secondary Outcome
Time to First Inappropriate Shock
Condition
Coronary Artery Disease
Study Arms / Comparison Groups
ICD Group (n=1500)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2285
Start Date
May 2014
Completion Date
November 2019
Primary Completion Date
May 2019
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Markus Zabel, MD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02064192
Organization ID
EU 602299
Responsible Party
Principal Investigator
Study Sponsor
University Medical Center Goettingen
Study Sponsor
Markus Zabel, MD, Principal Investigator, University Medical Center Goettingen
Verification Date
March 2020