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Conditions
Interventions
Group 1: This is a prospective, single-arm, multicentre, multinational, non-randomised study to evaluate the procedural safety and performance of the reBEAT system in patients with advanced heart fail
Sponsors
AdjuCor GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: 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. Primary performance endpoint: There are two primary performance endpoints during activation of the device: a) Reliable detection of epicardial ECG signals to allow for the mechanical synchronization of reBEAT system to the patient’s heartbeat in the diseased state. b) Favourable changes in one or more selected haemodynamic and/or echocardiography parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety endpoints: The secondary safety endpoints are defined as under: a) New ECG abnormalities, including the occurrence of arrhythmias and myocardial ischemia during the study. 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. Secondary performance endpoints: The secondary performance endpoints relate to procedural success which will be defined as: 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. | — |
Countries
Denmark, Germany, United Kingdom
Contacts
Public ContactStephan Schueler
Newcastle upon Tyne Freeman Hospitals NHS Foundation Trust; Freeman Hospital; Department for Cardiothoracic Surgery
Outcome results
None listed