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

Not Applicable

Recruiting

Conditions: I50.1
I50.13
I50.14
I50.0
I50.04
I50.05
I50.9
Left ventricular failure
Congestive heart failure
Heart failure, unspecified

Registration Number: DRKS00030769

Lead Sponsor: AdjuCor GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary safety endpoint:<br>The primary composite procedural safety endpoint is freedom from major adverse cardiovascular events (MACE) attributable to the implantation, operation (activation) and retrieval of the reBEAT system.<br><br>Primary performance endpoint:<br>There are two primary performance endpoints during activation of the device:<br>a) Reliable detection of epicardial ECG signals to allow for the mechanical synchronization of reBEAT system to the patient’s heartbeat in the diseased<br>state.<br>b) Favourable changes in one or more selected haemodynamic and/or echocardiography parameters.

Secondary Outcome Measures

Name	Time	Method
Secondary safety endpoints:<br>The secondary safety endpoints are defined as under:<br>a) New ECG abnormalities, including the occurrence of arrhythmias and myocardial ischemia during the study.<br>b) Any device-tissue interactions on the surface of the heart will be observed, i.e. the regions of the heart that are visible in the operating field without significant manipulation will be inspected for potential evidence of device-related injury.<br><br>Secondary performance endpoints:<br>The secondary performance endpoints relate to procedural success which will be defined as:<br>a) Absence of device malfunction resulting in the need for the procedure to be aborted. The incidence and frequency of device malfunctions that do not allow it to operate entirely as intended will be recorded.