Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000696493
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of irrigation fluid used during treatment of abnormal heart rhythms.
Scientific title
Assessing acute procedural success of ventricular tachycardia ablation in structural heart disease when using half-normal saline versus normal saline irrigation: randomized control trial
Secondary ID [1] 313728 0
None
Universal Trial Number (UTN)
Trial acronym
HANS-VT (SALT-VT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Structural heart disease 336506 0
Ventricular Tachycardia 336505 0
Condition category
Condition code
Cardiovascular 333014 333014 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiofrequency catheter ablation is a recommended approach to treating patients with ventricular tachycardia and structural heart disease. Catheter hardware is kept cool during the procedure using an irrigation fluid, typically 0.9% NaCl saline solution. Therapeutic current delivered by the catheter can be absorbed by the irrigation fluid. An alternative is 0.45% NaCl "half-normal" saline solution.
The irrigation flow rate (millilitres per min) of both normal saline and half-normal saline to keep catheters cool and prevent thrombosis is 2mL/min during diagnostic periods of the procedures and is increased to 8mL/min or 15mL/min during ablation, based on power setting used (e.g., 30 watts, 40 watts). The power is decided based on the operator discretion. As such, the volume of half-normal saline used will be dependent on the duration of the procedure and the amount of time spent delivering radiofrequency ablation.
Adherence to the intervention will take the form of operator compliance to the blinding aspect of the study. Intravenous bag covers (typically used to protect light-sensitive products) will be used to conceal the identity of the irrigation to clinical and study personnel who require blinding. Unblinded clinical team members will be limited but will include anaesthetics and nursing staff required to prepare bags saline bags. Unblinding will only take place if clinically required.
The intervention in this trial is 0.45% "half-normal" saline, which is routinely available for catheter ablation of ventricular tachycardia in structural heart disease.
Intervention code [1] 330433 0
Treatment: Other
Comparator / control treatment
The control in this trial is 0.9% normal saline, which is routinely which is the default irrigation fluid used during catheter ablation procedures.

The irrigation flow rate (millilitres per min) of both normal saline and half-normal saline to keep catheters cool and prevent thrombosis is 2mL/min during diagnostic periods of the procedures and is increased to 8mL/min or 15mL/min during ablation, based on power setting used (e.g., 30 watts, 40 watts). The power is decided based on the operator discretion. As such, the volume of half-normal saline used will be dependent on the duration of the procedure and the amount of time spent delivering radiofrequency ablation.
Control group
Active

Outcomes
Primary outcome [1] 340554 0
Acute procedural success in VT ablation.
Timepoint [1] 340554 0
Day 0 Ventricular tachycardia induction test will be performed at the end of the procedure.
Secondary outcome [1] 444454 0
Recurrent sustained ventricular tachycardia
Timepoint [1] 444454 0
Continuous assessment with ICD monitoring with formal assessment at 3-, 6- and 12-months post ablation, with continued follow-up to 24 months or until study end date (last patient has been followed for a minimum of 1 year).
Secondary outcome [2] 444458 0
All cause mortality
Timepoint [2] 444458 0
Until study end date (last patient has been followed for a minimum of 1 year).
Secondary outcome [3] 444457 0
Cardiovascular hospitalisation
Timepoint [3] 444457 0
3 ,6 and 12-monthly post ablation until study end date (last patient has been followed for a minimum of 1 year).
Secondary outcome [4] 444456 0
Ventricular tachycardia burden
Timepoint [4] 444456 0
Preceding 6 months compared to the 6 months after randomisation and therapy.
Secondary outcome [5] 444459 0
Composite endpoint of ventricular tachycardia recurrence, cardiac transplant and mortality.
Timepoint [5] 444459 0
3 ,6 and 12-monthly post ablation until study end date (last patient has been followed for a minimum of 1 year).

Eligibility
Key inclusion criteria
1. >=1 prior episode of sustained VT in the prior 6 months;
a. Spontaneous VT: >=1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting >=30 seconds in the absence of intra-cardiac device therapy that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
b. Spontaneous VT: >=1 episode of sustained spontaneous monomorphic VT lasting >=30 seconds documented on Holter, ECG, Loop recorder or other cardiac monitoring device that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
c. Inducible VT: with syncope or palpitations – inducible VT defined as sustained monomorphic VT of CL >=200 ms lasting for >=10 s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline);

2. Undergoing ventricular tachycardia ablation;
3. underlying structural heart disease;
4. a recipient of an implanted cardiac device such as a pacemaker, defibrillator or a cardiac resynchronisation therapy device and/or is indicated to receive one given a new diagnosis of structural heart disease, based on current guideline recommendations.
5. Aged >=18 years;
6. able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation;
2. Women who are pregnant, breast feeding;
3. Medical illness with an anticipated life expectancy <3 months;
4. Unable to complete study procedures or unwilling to be followed up;
5. Have a concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments;
6. patient with idiopathic ventricular arrhythmia
7. patient with structurally normal heart
8. known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis approach will be intention to treat and will compare the acute procedural success rate as the primary outcome in normal saline group and half normal saline group using survival analysis techniques. The time-to-event will be summarized using Kaplan-Meier product limit estimates and the non-parametric log rank test procedure will be used for comparing the survival curves. The null hypothesis is that the time-to-event of the primary outcome is not different between the ablation and medical therapy groups. The alternative hypothesis is that the time-to-event of the primary outcome is different between these therapy groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/02/2025
Date of last participant enrolment
Anticipated
29/01/2027
Actual
Date of last data collection
Anticipated
28/01/2028
Actual
Sample size
Target
70
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27560 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 43674 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 318195 0
Government body
Name [1] 318195 0
Western Sydney Local Health District (WSLHD)
Country [1] 318195 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District (WSLHD)
Address
Country
Australia
Secondary sponsor category [1] 320708 0
None
Name [1] 320708 0
Address [1] 320708 0
Country [1] 320708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316846 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316846 0
Ethics committee country [1] 316846 0
Australia
Date submitted for ethics approval [1] 316846 0
29/11/2023
Approval date [1] 316846 0
28/08/2024
Ethics approval number [1] 316846 0

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

Contacts
Principal investigator
Name 139182 0
A/Prof Saurabh Kumar
Address 139182 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 139182 0
Australia
Phone 139182 0
+612 8890 8981
Fax 139182 0
Email 139182 0
[email protected]
Contact person for public queries
Name 139183 0
Saurabh Kumar
Address 139183 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 139183 0
Australia
Phone 139183 0
+612 8890 8981
Fax 139183 0
Email 139183 0
[email protected]
Contact person for scientific queries
Name 139184 0
Saurabh Kumar
Address 139184 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country 139184 0
Australia
Phone 139184 0
+612 8890 8981
Fax 139184 0
Email 139184 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal, on a case-by-case at the discretion of the PI

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified patient demographics, study outcomes data

What types of analyses could be done with individual participant data?
• Collaborative research studies, meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
After publication of the results

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Through contacting the Primary Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    20240828 HREC Approval Email (2).pdf
Informed consent form    2023_ETH02779_v1_04 - PICF_v3 20240418 (2).docx
Study protocol    Protocol_v7 dated 04-12-2024_clean.docx


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.