MISSION-reBEAT: A pilot clinical investigation (First-in-Human) of a novel mechanical circulatory support system without blood contact, the reBEAT system, in advanced heart failure patients - MISSION-reBEAT

AdjuCor GmbH0 个研究点目标入组 15 人开始时间: 2023年7月28日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•a)Provision of written informed consent to participate in study
•b)Age 18-85 years
•c)Body surface area (BSA) = 1.4 m²
•d)Diagnosis of advanced heart failure selected for elective implantation of a durable, long term LVAD (e.g. Heartmate 3) by a multidisciplinary team, according to disease progression and indications
•e)Haemodynamically stable prior to surgery, having an INTERMACS class of 3 or higher

•a)Aetiology of heart failure (HF) due to, or associated with, uncorrected thyroid disease, obstructive/restrictive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
•b)Previous cardiac surgery.
•c)Patient does not agree to data sharing or informed consent.
•d)Technical or anatomical features associated with an unacceptably high surgical risk, in the judgment of the Principal Investigator.
•e)Ongoing psychosocial issues which, in the judgment of the Principal Investigator and/or multidisciplinary team, render the patient unsuitable for enrolment.
•f)Positive pregnancy test if of childbearing potential.
•g)Participation in any other clinical investigation that may compromise the scientific integrity of the study/studies.
•h)A patient with 100% pacemaker dependency.
•i)A relative contraindication has been identified by the PI or TMG that would present an unacceptable high risk to the patient within the context of the study intervention.
•Post-consent exclusion criteria
•a)Known or de novo detection of intracardiac thrombus by any method
•b)Appropriate anatomical fit of the Implant cannot be confirmed prior to, surgery.

发起方

AdjuCor GmbH