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

Not Applicable

Recruiting

Conditions: Cardiac Arrhythmia
Ventricular Tachycardia (VT)
Ventricular Fibrillation (VF)
Cardiovascular - Other cardiovascular diseases
Surgery - Other surgery

Registration Number: ACTRN12621000258853

Lead Sponsor: RRR Manufacturing Pty Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

EXCLUSION CRITERIA:
1. Patient is considered a member of a protected population
(Pregnant, prisoner, mentally incompetent, etc.)
2. Patient is enrolled in a competing/conflicting clinical trial
3. 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
4. Patient is institutionalised or is a known drug abuser, a known
alcoholic or cannot understand the requirements of study
participation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: To evaluate the efficacy of the CellAED to appropriately revert a patient in VT or VF to normal sinus rhythm. This is a composite assessment of the following:<br><br>- Device output (measured in Joules by the device)<br>- Device Current (measured in Amps by the device)<br>- Transthoracic impedance (measured in Ohm by the device)<br>- Reversion of VT or VF to normal sinus rhythm for at least 5 seconds, assessed using ECG[ This will be assessed immediate following the deployment of the CellAED therapy.]

Secondary Outcome Measures

Name	Time	Method
Safety: Patient Safety will be evaluated based on the frequency of adverse events (including local tissue trauma) across the trial, assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE, version 5).<br>[ This will be continually assessed for the duration of the surgical procedure and on a post-operative assessment at the conclusion of the surgery.];Clinical performance: This will be assessed by analysing the patient's heart rhythm using 12 lead ECG recorded during episode of VF or VT.[ This will be continually assessed for the duration of the surgical procedure.];Usability will be assessed using an evaluation form completed by the user (attending cardiologist, including assessment of Snap Peel Stick methodology. This is an evaluation form that has been designed specifically for this project.[ Completed within 1 hour post-operatively. ]