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

N/ACompletedNCT02064192

University Medical Center Goettingen2,285 enrolled

Overview

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.

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

Enrollment

2,285

Conditions

Coronary Artery Disease Myocardial Infarction Dilated Cardiomyopathy Implantable Defibrillator User

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (42)

KU Leuven, Div. of Cardiology

Leuven, Belgium

National Heart Hospital, Dept. of Cardiology

Sofia, Bulgaria

Acibadem City Clinic Tokuda Hospital, Div. of Cardiology

Sofia, Bulgaria

St. Ekaterina Hospital, Div. of Cardiology

Sofia, Bulgaria

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

Sofia, Bulgaria

Outcomes

Primary Outcomes

All-Cause Mortality

Co-Primary Endpoint

Time frame: one to five years

First Appropriate ICD Shock

Co-Primary Endpoint

Time frame: one to five years

Secondary Outcomes

Time to First Inappropriate Shock

Time frame: one to five years

Sudden Cardiac Death

Time frame: one to five years

Cardiac Death

Time frame: one to five years

Non-Cardiac Death

Time frame: one to five years

Arrhythmogenic Syncope

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

Time frame: one to five years

Resuscitation

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

Time frame: one to five years

Any ICD Shock

any ICD shock (appropriate or inappropriate)

Time frame: one to five years

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

Time frame: one to five years

Quality of Life

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

Time frame: one to five years

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

Time frame: one to five years

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

Time frame: one to five years