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Trial registered on ANZCTR


Registration number
ACTRN12624000304538
Ethics application status
Approved
Date submitted
21/02/2024
Date registered
22/03/2024
Date last updated
31/10/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
COMPARison of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP
Scientific title
COMPARison of procedural outcomes of Lumenless versus Stylet-driven Lead Systems in Left Bundle Branch Pacing - COMPARE LBBP
Secondary ID [1] 311567 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 332937 0
Heart failure 332938 0
Pacemaker induced cardiomyopathy 332965 0
Condition category
Condition code
Cardiovascular 329654 329654 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Left bundle branch pacing (LBBP) is a rapidly emerging pacing modality. Traditionally, lumenless fixed helix lead is used for LBBP delivered with a fixed curve or preshaped deflectable delivery catheter. However, it can also be done with stylet driven lead when used with appropriate delivery catheter. In this clinical trial one arm will receive lumen less lead and another will receive stylet driven lead for LBBP. No investigational therapy is involved as both methods are tested and currently in use.
Intervention arm will receive stylet driven lead system. LBBP will be performed with stylet driven lead delivered to target location through a delivery catheter. A pre-shaped delivery catheter (such as CPS Locator 3D sheth) will be used which is standard of care. Left bundle capture will be confirmed by paced RBBB morphology plus one of the following.
1. V6-R wave peak time <75 ms in patients with narrow QRS and <80 ms in patients with bundle branch block, 2. V6-V1 inter peak interval of >44 ms, 3. transition from nonselective to selective left bundle branch or left ventricular septal capture. 'Template beat' be used to guide the procedure if induced during lead implantation.
Procedure will be performed once and confirmation of left bundle branch capture will be considered acute success. Usual procedural duration is ~1-2 hours. Procedure will be performed by experienced cardiac electrophysiologist specialised in left bundle branch pacing.
Another cardiac electrophysiologist will be independently responsible for validating the left bundle branch capture and independent team of cardiac physiologists will be responsible for collecting data regarding procedure start, end and electrocardiographic parameters.
Intervention code [1] 328022 0
Treatment: Devices
Comparator / control treatment
Lumenless lead for LBBP
Control group
Active

Outcomes
Primary outcome [1] 337442 0
Acute implant success rate
Timepoint [1] 337442 0
At implant
Secondary outcome [1] 431869 0
Terminal r/R' wave in lead V1 - Right Bundle Branch Block morphology in lead V1
Timepoint [1] 431869 0
At implant
Secondary outcome [2] 431870 0
Transition from non-selective to selective LBBP or non-selective LBBP to left ventricular myocardial capture during decreasing pacing output
Timepoint [2] 431870 0
At implant
Secondary outcome [3] 431871 0
Abrupt shortening of stimulus to R wave peak time in V6 ECG lead (V6RWPT) by 10 ms or more during implantation
Timepoint [3] 431871 0
At implant
Secondary outcome [4] 431872 0
V6RWPT < 75ms or < 80ms in patients with preexisting bundle branch block
Timepoint [4] 431872 0
At implant
Secondary outcome [5] 431873 0
An interpeak interval (V1RWPT - V6RWPT) > 33ms
Timepoint [5] 431873 0
At implant
Secondary outcome [6] 431874 0
Implant related complications
Timepoint [6] 431874 0
Immediate post procedure period
Secondary outcome [7] 441189 0
Persistence of LBBP on follow up
Timepoint [7] 441189 0
Secondary outcome [8] 441190 0
Persistence of LBBP on follow up
Timepoint [8] 441190 0
1 month, 3 month and 6 months post-implant
Secondary outcome [9] 441191 0
Lead implant time
Timepoint [9] 441191 0
1 month, 3 month and 6 months post-implant
Secondary outcome [10] 441192 0
Lead implant time
Timepoint [10] 441192 0
At the time of implant
Secondary outcome [11] 441193 0
Lead implant attempts
Timepoint [11] 441193 0
At the time of implant
Secondary outcome [12] 441194 0
Lead implant attempts
Timepoint [12] 441194 0
At the time of the implant.
Secondary outcome [13] 441195 0
Fluoroscopy dose
Timepoint [13] 441195 0
At the time of the implant.
Secondary outcome [14] 441196 0
Fluoroscopy dose
Timepoint [14] 441196 0
At the time of implant.
Secondary outcome [15] 441197 0
Fluoroscopy time
Timepoint [15] 441197 0
At the time of implant.
Secondary outcome [16] 441198 0
Fluoroscopy time
Timepoint [16] 441198 0
At the time of the implant.
Secondary outcome [17] 441199 0
Lead damage during implantation requiring a new lead for implant.
Timepoint [17] 441199 0
At the time of the implant.
Secondary outcome [18] 441200 0
Lead damage during implantation requiring a new lead for implant.
Timepoint [18] 441200 0
At the time of the implant
Secondary outcome [19] 441201 0
Lead dislodgement requiring repeat procedure.
Timepoint [19] 441201 0
At the time of the implant
Secondary outcome [20] 441202 0
Lead dislodgement requiring repeat procedure.
Timepoint [20] 441202 0
Acute dislodgement measured in post-index procedure period up to the time of discharge. Late dislodgement measured in the follow up period after discharge from hospital.

Eligibility
Key inclusion criteria
a) Age: 18 years and above
b) Recipients of left bundle branch pacing therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Metallic tricuspid valve implant
b) Severe tricuspid stenosis
c) Complex congenital heart disease, dextrocardia.
d) Venous anatomy unsuitable for transvenous pacing - e.g venous stenosis, congenital malformation
e) Venous anatomy or any other pathology precluding pacing from left sided vein
e) Upgrade from a failed His bundle pacing
f) Highly dependent or with mental impairment
g) Pregnant women
h) Inability to follow up, interstate patients
i) Refuse to/unable to give consent

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 phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/11/2023
Date of last participant enrolment
Anticipated
15/05/2024
Actual
31/05/2024
Date of last data collection
Anticipated
31/05/2024
Actual
26/08/2024
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 315867 0
Self funded/Unfunded
Name [1] 315867 0
Country [1] 315867 0
Primary sponsor type
Charities/Societies/Foundations
Name
Canberra heart rhythm foundation
Address
Country
Australia
Secondary sponsor category [1] 318006 0
None
Name [1] 318006 0
Address [1] 318006 0
Country [1] 318006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314716 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 314716 0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Ethics committee country [1] 314716 0
Australia
Date submitted for ethics approval [1] 314716 0
19/10/2023
Approval date [1] 314716 0
16/11/2023
Ethics approval number [1] 314716 0

Summary
Brief summary
Left bundle branch pacing (LBBP) is rapidly emerging pacing therapy. Traditionally, lumenless fixed helix lead is used for LBBP which is delivered through a fixed curve or preshaped flexible curve delivery catheter. Left bundle area can also be captured with implantation of traditional stylet-driven leads delivered with the use of various delivery sheaths from different manufacturers. Currently, both techniques are in use; however, data regarding comparison of outcomes of these two different lead systems is limited. This trial aims at comparing the outcomes of these two different techniques of LBBP which are currently in use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132498 0
Prof Rajeev Kumar Pathak
Address 132498 0
Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
Country 132498 0
Australia
Phone 132498 0
+61477653949
Fax 132498 0
Email 132498 0
[email protected]
Contact person for public queries
Name 132499 0
Rajeev Kumar Pathak
Address 132499 0
Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
Country 132499 0
Australia
Phone 132499 0
+61477653949
Fax 132499 0
Email 132499 0
[email protected]
Contact person for scientific queries
Name 132500 0
Rajeev Kumar Pathak
Address 132500 0
Canberra heart rhythm, Suite 14, 2 Garran Pl, Garran, ACT-2605
Country 132500 0
Australia
Phone 132500 0
+61477653949
Fax 132500 0
Email 132500 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21687Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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