Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000062628
Ethics application status
Approved
Date submitted
3/11/2022
Date registered
18/01/2023
Date last updated
4/07/2024
Date data sharing statement initially provided
18/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The treatment of participants with ventricular tachycardia by exposure to a single dose of ionising radiation.
Scientific title
Assessment of the acute safety of cardiac stereotactic ablative radiotherapy for the treatment of ventricular tachycardia
Secondary ID [1] 308248 0
Nil known
Universal Trial Number (UTN)
U1111-1284-2741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular tachycardia 328026 0
Condition category
Condition code
Cardiovascular 325088 325088 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants with VT will screened to meet the eligibility criteria by the treating cardiologist.
They will then undergo ECG and cardiac CT scans to determine the region of the heart that is causing the VT events. These will take approximately 1 hour each.

Each participant will attend radiation oncology for the radiotherapy simulation session typically within a week of the cardiac screening session. During the radiotherapy simulation session, they will have two CT scans of the chest region: one being conventional CT scan and the second will be a gated 4D CT scan. This session takes about 1 hour.

The imaging data from cardiology and radiation oncology will be combined in the radiotherapy treatment planning system to help determine the region of the heart that will be treated with a dose of 25 Gy in 1 treatment fraction. This will be done under the direction of the radiation oncologist and cardiologist. The treatment plan will be reviewed by the trial team and then undergo the radiotherapy quality assurance processes prior to treatment.

This is followed by the radiation treatment session in radiation oncology on the linear accelerator. The treatment session will occur between 1 to 2 weeks after the radiotherapy simulation session. The radiation beam will be delivered in several arcs targeting the region of interest. Cone-beam CT imaging will be performed at the start and during the treatment to ensure we are irradiating the region of interest in the heart. The time required for the radiotherapy session will be approximately one hour. The radiotherapy treatment will be delivered by the radiation therapists with the radiation oncologist and cardiologist attending for the duration of the treatment.
Intervention code [1] 324709 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333008 0
Safety of non-invasive cardiac stereotactic ablative radiotherapy will be assessed through the review of serious adverse events (SAEs) using CTCAE v5.0 criteria that are possibly/probably/definitely related to study treatment based on previously published data for expected invasive catheter-based VT-ablation procedures.

Examples of adverse events include an acute worsening of heart failure symptoms requiring new medications and/or a reduction in left ventricular ejection fraction both within the first six week; pericarditis; heart failure; allergic reactions; diarrhea; nausea.
Timepoint [1] 333008 0
1 month, 3, 6 and 12 months after the radiotherapy treatment session
Primary outcome [2] 333011 0
The efficacy of the non-invasive cardiac stereotactic ablative radiotherapy will be assessed by comparing the number of VT episodes requiring treatment by Implantable Cardioverter Defibrillator or external defibrillator before and after the radiotherapy treatment session. The primary efficacy endpoint will be determined by comparing total number of VT episodes in the six months after radiotherapy compared to the 6-month period preceding the radiotherapy. This data will be collected via a data-linkage to the medical record of the participant.
Timepoint [2] 333011 0
6 months after the radiotherapy treatment session.
Secondary outcome [1] 415528 0
Determine the six-month and twelve-month survival (overall mortality endpoint) after treatment with radiotherapy.
Timepoint [1] 415528 0
6 and 12 months after the radiotherapy treatment session.
Secondary outcome [2] 415529 0
The number of adverse events that are possibly/probably/definitely related to the study treatment. Possible serious adverse effects include cardio-circulatory arrest, acute myocardial infarction, cardiogenic shock, pericarditis, myocarditis, and/or endocarditis, acute heart failure gastroesophageal lesion, bronchopulmonary infection and injury to the respiratory system. These will assessed by clinical examination.
Timepoint [2] 415529 0
3, 6 and 12 months after the radiotherapy treatment session.
Secondary outcome [3] 415531 0
Measures of the Health Related Quality of Life (HRQOL) of participants
Timepoint [3] 415531 0
Baseline, 4 weeks, 3 months, 6 months and 12 months after the radiotherapy session.
Secondary outcome [4] 415532 0
Any change in Left Ventricle Ejection Fraction (LVEF) as assessed by echocardiography scans.
Timepoint [4] 415532 0
Baseline, 3 months, 6 months and 12 months after the radiotherapy treatment session.

Eligibility
Key inclusion criteria
1. The participant must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation
— OR—
b. Monomorphic PVCs documented on a 12-lead ECG.

2. The patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine).
–AND—
3. The participant must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery).

4. Participant must have either at least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrolment
–OR—
b. >20% PVC burden with a cardiomyopathy (LVEF<50%)

5. Participant must be deemed medically fit for stereotactic ablative body radiotherapy by the treating cardiologist and radiation oncologist.

6. Participant must be over the age of 18 years old.

7. Participant must have willingness to provide informed consent and a willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior radiotherapy within the treatment field

2. Heart failure dependent on inotropes or left-ventricular assist device

3. Ventricular fibrillation, >3 distinct clinical VT morphologies or > 5 VT induced VT morphologies during previous electrophysiology studies.

4. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician

5. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to analyse the survey responses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
8/09/2023
Date of last participant enrolment
Anticipated
31/03/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23434 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 23435 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 38836 0
2050 - Camperdown
Recruitment postcode(s) [2] 38837 0
2050 - Missenden Road

Funding & Sponsors
Funding source category [1] 312328 0
Hospital
Name [1] 312328 0
Chris O'Brien Lifehouse
Country [1] 312328 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 314195 0
None
Name [1] 314195 0
Address [1] 314195 0
Country [1] 314195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311695 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311695 0
Ethics committee country [1] 311695 0
Australia
Date submitted for ethics approval [1] 311695 0
22/02/2022
Approval date [1] 311695 0
03/02/2023
Ethics approval number [1] 311695 0
2022/ETH02275

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

Contacts
Principal investigator
Name 122030 0
Dr Robin Hill
Address 122030 0
Department of Radiation Oncology
Chris O'Brien Lifehouse
119 - 133 Missenden Road
Camperdown NSW 2050
Country 122030 0
Australia
Phone 122030 0
+61 285140233
Fax 122030 0
Email 122030 0
[email protected]
Contact person for public queries
Name 122031 0
Robin Hill
Address 122031 0
Department of Radiation Oncology
Chris O'Brien Lifehouse
119 - 133 Missenden Road
Camperdown NSW 2050
Country 122031 0
Australia
Phone 122031 0
+61 285140233
Fax 122031 0
Email 122031 0
[email protected]
Contact person for scientific queries
Name 122032 0
Robin Hill
Address 122032 0
Department of Radiation Oncology
Chris O'Brien Lifehouse
119 - 133 Missenden Road
Camperdown NSW 2050
Country 122032 0
Australia
Phone 122032 0
+61 285140233
Fax 122032 0
Email 122032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the clinical trial will be shared.
When will data be available (start and end dates)?
This data will be made available dependent on the case-by-case basis at the discretion of primary sponsor. This would be following any publication and there would be no end date.
Available to whom?
This would be decided on a case-by-case basis at the discretion of the primary sponsor.
Available for what types of analyses?
IPD Meta-analysis or as part of other cardiac SABR registeries.
How or where can data be obtained?
This would be done on case-by-case basis at the discretion of the primary sponsor who can be contacted by email at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.