Sudden cardiac death
Conditions
Interventions
None listed
Sponsors
University Medical Center Göttingen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is all-cause mortality. Co-primary endpoint is the time to first appropriate shock as defined as an ICD high voltage therapy delivered appropriately for malignant ventricular arrhythmia (per judgement of the investigator and the endpoint committee). | — |
Secondary
| Measure | Time frame |
|---|---|
| -ICD Electrical Shock Endpoints (including Inappropriate ICD Shock) -Mortality Endpoints (SCD, Cardiac Death and Non-Cardiac Death) -other Clinical Endpoints: Arrhythmogenic Syncope, Resuscitation, Any ICD Shock, Atrial Fibrillation -Quality of Life -Device Revision/Replacement -Costs and Cost-effectiveness | — |
Countries
Netherlands
Outcome results
None listed