Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000258853
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
10/03/2021
Date last updated
20/06/2023
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre, prospective, safety and efficacy evaluation study of automated external defibrillation (CellAED) in patients with cardiac arrythmias.
Scientific title
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.
Secondary ID [1] 303139 0
None
Universal Trial Number (UTN)
U1111-1260-7791
Trial acronym
RAPID I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrhythmia 320249 0
Ventricular Tachycardia (VT) 320250 0
Ventricular Fibrillation (VF) 325247 0
Condition category
Condition code
Cardiovascular 318181 318181 0 0
Other cardiovascular diseases
Surgery 318182 318182 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319468 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326198 0
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:

- Device output (measured in Joules by the device)
- Device Current (measured in Amps by the device)
- Transthoracic impedance (measured in Ohm by the device)
- Reversion of VT or VF to normal sinus rhythm for at least 5 seconds, assessed using ECG
Timepoint [1] 326198 0
This will be assessed immediate following the deployment of the CellAED therapy.
Secondary outcome [1] 390475 0
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).
Timepoint [1] 390475 0
This will be continually assessed for the duration of the surgical procedure and on a post-operative assessment at the conclusion of the surgery.
Secondary outcome [2] 390476 0
Clinical performance: This will be assessed by analysing the patient's heart rhythm using 12 lead ECG recorded during episode of VF or VT.
Timepoint [2] 390476 0
This will be continually assessed for the duration of the surgical procedure.
Secondary outcome [3] 390477 0
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.
Timepoint [3] 390477 0
Completed within 1 hour post-operatively.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Successful delivery of shock: Efficacy of the defibrillation will be evaluated by the successful termination of the VT/VF episode and reversion to a NSR for a period of 5 seconds.

The secondary objectives will be assessed using descriptive statistics. Categorical variables will be summarized by frequencies and percentages. Continuous variables will be summarized by means, standard deviations, minimums, medians and maximums where appropriate. Confidence intervals will be calculated as appropriate. Type 1 error for the study will be set to 0.05.
Calculation of sample size is based on previously published literature suggesting adequate sample size to demonstrate the efficacy of defibrillation to revert a patient to NSR. There are a variety of factors including ischemia, metabolic or electrolyte derangements, autonomic tone, and medications can affect the success of defibrillation. We have selected a number large enough to demonstrate efficacy, while reducing the number of patients exposed to therapy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2021
Actual
31/05/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
25
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 18413 0
The Alfred - Melbourne
Recruitment hospital [2] 23683 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 23684 0
The Sutherland Hospital - Caringbah
Recruitment hospital [4] 24148 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 32508 0
3004 - Melbourne
Recruitment postcode(s) [2] 39114 0
2031 - Randwick
Recruitment postcode(s) [3] 39115 0
2229 - Caringbah
Recruitment postcode(s) [4] 39660 0
2145 - Westmead
Recruitment outside Australia
Country [1] 23375 0
New Zealand
State/province [1] 23375 0
Christchurch
Country [2] 23376 0
New Zealand
State/province [2] 23376 0
Waikato
Country [3] 23377 0
New Zealand
State/province [3] 23377 0
Auckland

Funding & Sponsors
Funding source category [1] 307543 0
Commercial sector/Industry
Name [1] 307543 0
RRR Manufacturing Pty Ltd
Country [1] 307543 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RRR Manufacturing Pty Ltd
Address
2-6 Skinner Ave, Riverwood NSW 2210
Country
Australia
Secondary sponsor category [1] 308230 0
None
Name [1] 308230 0
Address [1] 308230 0
Country [1] 308230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307609 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307609 0
55 Commercial Road, Melbourne Vic 3004
Ethics committee country [1] 307609 0
Australia
Date submitted for ethics approval [1] 307609 0
07/12/2020
Approval date [1] 307609 0
09/03/2021
Ethics approval number [1] 307609 0
HREC/72506/Alfred-2021

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107850 0
A/Prof Dion Stub
Address 107850 0
Alfred Hospital Heart Centre
3rd Floor WS Phillip Block
Commercial Road, Melbourne, VIC 3004
Country 107850 0
Australia
Phone 107850 0
+61 3 9076 3263
Fax 107850 0
Email 107850 0
D.Stub@alfred.org.au
Contact person for public queries
Name 107851 0
A/Prof Dion Stub
Address 107851 0
Alfred Hospital Heart Centre
3rd Floor WS Phillip Block
Commercial Road, Melbourne, VIC 3004
Country 107851 0
Australia
Phone 107851 0
+61 1300765865
Fax 107851 0
Email 107851 0
D.Stub@alfred.org.au
Contact person for scientific queries
Name 107852 0
A/Prof Dion Stub
Address 107852 0
Alfred Hospital Heart Centre
3rd Floor WS Phillip Block
Commercial Road, Melbourne, VIC 3004
Country 107852 0
Australia
Phone 107852 0
+61 1300765865
Fax 107852 0
Email 107852 0
D.Stub@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results