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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 88

Inclusion Criteria

-Ischaemic or non-ischaemic (dilated) cardiomyopathy and recommendation for primary prophylactic ICD treatment following current international treatment guidelines
-Age * 18 years
-Written informed consent
-If ICD implantation is planned, enrolment and study baseline testing needs to be completed before de-novo ICD implantation

Exclusion Criteria

-Persistent or permanent atrial fibrillation in the baseline ECG recordings in no more than 15% of such patients at a given time have been enrolled, thus atrial fibrillation is an exclusion criteria only if this percentage has been surpassed in the overall enrolled patient population
-Indication for other than above mentioned primary prophylactic ICD treatment
-Indication for secondary prophylactic ICD treatment
-Indication or candidate for cardiac resynchronisation therapy, i.e.: (1) QRS duration of *135 ms, left bundle branch block QRS morphology, and an LVEF *35% or (2) QRS duration *150 ms, irrespective of QRS morphology, and an EF *35%
-QRS duration of 120-130 msec, left bundle branch block QRS morphology, and an EF *35%, if the investigator deems cardiac reysnchronisation therapy indicated
-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 & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is all-cause mortality. Co-primary endpoint is the time<br /><br>to first appropriate shock as defined as an ICD high voltage therapy delivered<br /><br>appropriately for malignant ventricular arrhythmia (per judgement of the<br /><br>investigator and the endpoint committee).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-ICD Electrical Shock Endpoints (including Inappropriate ICD Shock)<br /><br>-Mortality Endpoints (SCD, Cardiac Death and Non-Cardiac Death)<br /><br>-other Clinical Endpoints: Arrhythmogenic Syncope, Resuscitation, Any ICD<br /><br>Shock, Atrial Fibrillation<br /><br>-Quality of Life<br /><br>-Device Revision/Replacement<br /><br>-Costs and Cost-effectiveness</p><br>