Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe - EU-CERT-ICD study

niversity Medical Center Göttingen0 个研究点目标入组 88 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-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

•-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

发起方

niversity Medical Center Göttingen