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

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.

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

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