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

Plain Language Summary

Simplified for easier understanding

Every minute counts when someone goes into cardiac arrest, and having a defibrillator (a device that delivers an electric shock to restore normal heart rhythm) nearby can be life-saving. CellAED is a new type of automated external defibrillator (AED) that has been designed to be smaller and more portable than conventional models. This study is testing whether CellAED can safely and effectively deliver a defibrillating shock during a planned cardiac procedure where patients are likely to experience a treatable abnormal heart rhythm. Participants are adults aged 18 or over who are already scheduled for a routine cardiac procedure where episodes of ventricular tachycardia (VT) or ventricular fibrillation (VF) — both life-threatening but treatable rhythms — are likely to occur. The CellAED device is placed on the patient's chest before the procedure begins. A standard defibrillator is also on hand as a backup if the CellAED shock is not fully effective. This study is not looking at people who go into unexpected cardiac arrest — it is a controlled setting designed to evaluate whether this novel, compact device works as intended. The results will support regulatory approval and the potential rollout of CellAED as an accessible defibrillator option for community use.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.