Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001069347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/08/2026
Date registered
Help: Date registered
31/08/2026
Date last updated
Help: Date last updated
31/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
31/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Conduction system Assessment using Physiological criTeria for Realtime Evaluation for Left Bundle Branch Pacing (CAPTURE-LBBP)
Scientific title
Conduction system Assessment using Physiological criTeria for Realtime Evaluation for Left Bundle Branch Pacing (CAPTURE-LBBP) in Adult patinets.
Additional trial identifiers [1] 318188 0
2025/GEM00682
Universal Trial Number (UTN)
U1111-1345-4019
Trial acronym
CAPTURE-LBBP
Related trial records

Health condition
Health condition(s) studied:
Bradycardia requiring permanent pacemaker implantation 343247 0
Condition category
Condition code
Cardiovascular 339357 339357 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
INTERVENTION ARM (LPAC arm): Pacemaker implantation using Left Bundle Branch Area Pacing (LBBAP) with the TorqView device (LPAC — Electrical-only medical device connection adaptor, single-use; Trade name: TorqView; Manufacturer: Actis Medical Pty Ltd; ARTG No. 65159). TorqView is adminsterred by the implanting clinician who connects it to the pacing lead during the implant procedure. The TorqView provides continuous, beat-by-beat real-time electrical signal monitoring during lead placement, allowing the implanting physician to assess electrical connectivity in real time throughout the procedure. TorqView is used for the duration of the pacemaker lead implantation (~30minutes). Adherence to the intervention will be observed through the patient 'pacemaker implant form' where all devices used duirng the procedure are recorded.
Intervention code [1] 335085 0
Treatment: Devices
Description of the comparator or control
CONTROL ARM (Standard care): Pacemaker implantation using LBBAP guided by standard clinical practice without TorqView, where the implanting physician uses removable alligator clips to attach to the pacing lead before the lead screw-in phase to 'map' desired implant location, and then disconnects the alligator during lead screw-in, and then re-connects the alligator after the desired depth of the lead has been acheived. This represents current standard of care for LBBAP implantation.
Control group
Active

Outcomes
Primary outcome [1] 346562 0
(i) Change in R-wave peak time in Lead V6, as an electrical marker of synchronisation
Timepoint [1] 346562 0
Endpoint is verified at patient device follow-up clinic visit after acquiring device parameters and ECG.
Secondary outcome [1] 466389 0
Successful physiological left bundle branch (LBB) capture at the end of the index procedure as measured by decremental pacing after lead deployment to observe transition from non-selective to selective LBB capture
Timepoint [1] 466389 0
Offline, post-procedure
Secondary outcome [2] 466390 0
Known complications are those that are know relating to pacemaker device-related implant complications; bruising, bleeding, infection, or lead movement.
Timepoint [2] 466390 0
Offline, post procedure
Secondary outcome [3] 466391 0
Fluoroscopy dose used for implant
Timepoint [3] 466391 0
Offline, post-procedure
Secondary outcome [4] 466392 0
Procedure durration
Timepoint [4] 466392 0
Offline, post procedure
Secondary outcome [5] 466393 0
Change in left ventricular ejection fractin (LVEF).
Timepoint [5] 466393 0
Baseline (pre-procedure), and 6 months echocardiogram post procedure.
Secondary outcome [6] 466394 0
6 Minute Walk Test Distance
Timepoint [6] 466394 0
6 months post implant procedure
Secondary outcome [7] 466395 0
Quality of LIfe
Timepoint [7] 466395 0
Baselline, 6 months post implant procedure

Eligibility
Key inclusion criteria
Inclusion: Patients will be considered eligible to participate in the study if:
(i) aged greater or equal to 18 years of age
(ii) written informed consent
(iii) willing to be randomised
(iv) are being implanted with a lumenless LBBP pacing lead as part of their care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Patients will be excluded if they:
(i) Under the age of 18
(ii) have a life expectancy considered to be less than 12 months
(iii) Patients unable to provide informed consent for pacemaker implant, will be excluded from participation in the trial

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)
Patients are enrolled into the study before randomisation.
To ensure allocation concealment, randomisation will be managed using sequentially numbered, opaque, sealed envelopes (SNOSE) which will be placed in the nursing station at the pacemaker lab.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated and held within a secure, access-controlled system that is unavailable to recruiting investigators, implanting clinicians and outcome assessors. After eligibility has been confirmed and written informed consent obtained, an authorised study team member will enter the participant’s details and the assigned treatment will then be released immediately before the procedure.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this randomized controlled trial was determined based on the primary continuous outcome variable. The calculation was designed to provide 90% statistical power to detect a Minimum Clinically Important Difference (MCID) of 5.0 ms between the LPAC and Control groups, an effect size deemed clinically meaningful. The variance estimate was derived from preliminary data (n=26), yielding a pooled standard deviation of 8.61. Using a two-sided significance level (alpha) of 0.025 to minimize the risk of a Type I error, a sample size of 74 subjects per group is required. To account for a potential 10% attrition rate due to factors such as procedural failure and crossover, the recruitment target has been adjusted upwards to 83 subjects per group. Therefore, a total of 166 participants will be recruited to ensure adequate power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
166
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 30001 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 30002 0
Flinders Private Hospital - Bedford Park
Recruitment postcode(s) [1] 46397 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 322754 0
Government body
Name [1] 322754 0
Southern Adelaide Local Health Network
Country [1] 322754 0
Australia
Primary sponsor type
Hospital
Name
Southern Adelaide Local Health Network (Flinders Medical Centre)
Address
Country
Australia
Secondary sponsor category [1] 325676 0
University
Name [1] 325676 0
Flinders University
Address [1] 325676 0
Country [1] 325676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321192 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 321192 0
Ethics committee country [1] 321192 0
Australia
Date submitted for ethics approval [1] 321192 0
11/11/2025
Approval date [1] 321192 0
14/08/2026
Ethics approval number [1] 321192 0

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

Contacts
Principal investigator
Name 152966 0
Prof Anand Narayan Ganesan
Address 152966 0
Department of Cardiology, Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152966 0
Australia
Phone 152966 0
+61 8 8204 5619
Fax 152966 0
Email 152966 0
[email protected]
Contact person for public queries
Name 152967 0
Anand Narayan Ganesan
Address 152967 0
Dept Cardiology, Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152967 0
Australia
Phone 152967 0
+61 8 8204 5619
Fax 152967 0
Email 152967 0
[email protected]
Contact person for scientific queries
Name 152968 0
Anand Narayan Ganesan
Address 152968 0
Dept Cardiology, Flinders Private Hospital, Ste 606, Level 6/1 Flinders Dr, Bedford Park SA 5042
Country 152968 0
Australia
Phone 152968 0
+61 8 8204 5619
Fax 152968 0
Email 152968 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This has not been supported by our ethics application.



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.