RecruitingACTRN12621000258853

A multi-centre, prospective, safety and efficacy evaluation study of automated external defibrillation (CellAED) in patients with cardiac arrythmias.

A multi-centre, single arm, prospective, pre-market safety and efficacy evaluation study on automated external defibrillator (CellAED) to terminate arrhythmias in patients (VT or VF) and restore normal sinus rhythm.

Sponsor

RRR Manufacturing Pty Ltd

Enrollment

25 participants

Start Date

May 31, 2021

Study Type

Interventional

Conditions

Ventricular Fibrillation (VF)Cardiac Arrhythmia Ventricular Tachycardia (VT)

Summary

The CellAED device is a novel automated external defibrillator (AED) or commonly referred to as a defibrillator. The purpose of this study is to test this new AED and demonstrate its ability to deliver an appropriate shock to help restore a patient in cardiac arrest to a normal heart rhythm. The hypothesis is that the CellAED will be able to terminate arrhythmias (VT or VF) in a patient to allow the heart to restore a Normal Sinus Rhythm. Once consented, patients will be scheduled for the cardiac procedure. Patients will have the CellAED applied to their chest prior to the procedure starting. In addition, as a safety precaution, patients will have a traditional defibrillator applied to their chest as a rescue therapy device should the first shock delivered by the CellAED fail to revert the patient to normal sinus rhythm. During the procedure, if patient experiences a shockable rhythm (VT/VF) the cardiologist will activate the CellAED (in accordance with instructions in the Instructions for Use). This will be performed up to a maximum of one (1) time. The rhythm will be immediately assessed and if required, back up defibrillation will be delivered utilizing the standard defibrillator available on site.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Patients scheduled for a routine cardiac procedure where they
are likely to experience episodes of VT/VF
Patient is willing and able to provide written Informed Consent
by signing and dating the relevant Ethics Committee approved
Informed Consent
Patient is 18 years of age or older

Exclusion Criteria9

Patient is considered a member of a protected population
(Pregnant, prisoner, mentally incompetent, etc.)
Patient is enrolled in a competing/conflicting clinical trial
Patient has a condition which would, in the judgement of the
investigator, place the patient at undue risk or interfere with
the conduct of the study
Patient is institutionalised or is a known drug abuser, a known
alcoholic or cannot understand the requirements of study
participation

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Interventions

Once suitable participants have signed the consent form, they will undergo a cardiac procedure. These participants are patients who are already having a planned procedure where they are likely to experience Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF). The CellAED device is a novel automated external defibrillator. The cardiologist will place the CellAED onto the patient's chest once in theatre, prior to the commencement of surgery. During the procedure, participants will be connected to the CellAED, along with a back-up defibrillator. Once patients experience an arrhythmia (either spontaneous or induced), the CellAED will be deployed to deliver a defibrillation therapy and revert the patient to normal sinus rhythm. This will only be applied to a maximum of 1 time. A back up standard defibrillator will be used if the Cell AED device fails to successfully restore normal rhythm following a single shock delivery from the CellAED. The CellAED will then be removed from the patient. The use of the CellAED will be confined to the duration of the surgical procedure only. The use of the device including placement, therapy delivered, and outcome, will be reported in the patients medical records. Prior to surgery, all involved staff members will be trained on the appropriate use of the CellAED device in a single 30 minute training session. This training will be provided by the study sponsor onsite at the hospital in a one-to-one training session and will utilize a CellAED trainer device. All training will be documented and only trained users will be able to use the device. All users will have access to the trainer device and the instructions for use (IFU) document. This IFU document has been created specifically for this trial.