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Trial registered on ANZCTR


Registration number
ACTRN12624001420538
Ethics application status
Approved
Date submitted
17/11/2024
Date registered
4/12/2024
Date last updated
4/12/2024
Date data sharing statement initially provided
4/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of clinical outcomes of left bundle branch pacing vs right ventricular pacing in patients with normal left ventricular function or mild dysfunction
Scientific title
Comparison of clinical outcomes of left bundle branch pacing vs right ventricular pacing in patients with normal left ventricular function or mild dysfunction
Secondary ID [1] 313393 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pacing induced cardiomyopathy 335761 0
Condition category
Condition code
Cardiovascular 332318 332318 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Left bundle branch area pacing (LBBAP) will be studied. LBBAP involves implanting the pacing lead in the left bundle branch (LBB) or left ventricular septal location. The intervention will be performed in pacing indicated patients randomized to LBBAP arm. In LBBAP, the ventricular lead is implanted deep in the septum to capture LBB or left ventricular septum (LVS). The final location of the lead is determined based on electrocardiographic criteria as below:

Paced RBBB morphology plus at least one of the following:
1. R wave peak time in lead V6 <80 ms in patients with a bundle branch block and <75 ms in patients with narrow complex QRS
2. Transition from non-selective to selective LBB or left ventricular septal capture seen
3. V6-V1 interval <44 ms
The intervention will be performed by cardiac electrophysiologist with >5 years of experience in implanting LBBAP pacemaker. The intervention will be performed only once during the study unless lead failure or infection mandates lead revision/removal. The intervention will be performed at National Capital Private Hospital. The usual duration to perform this LBBAP implant is 60-90 mins. ECGs will be done at each follow up to monitor persistence of LBB/LVS capture.
Intervention code [1] 329970 0
Treatment: Devices
Comparator / control treatment
Right ventricular pacing (RVP) will be the comparator arm. RVP is a standard pacing strategy for >6 decades. The pacing lead is implanted into the right ventricular apex or right ventricular septum.
Control group
Active

Outcomes
Primary outcome [1] 339897 0
Left ventricular ejection fraction
Timepoint [1] 339897 0
Baseline, 6 months and 12 months post-implantation
Secondary outcome [1] 441838 0
Left ventricular end-systolic volume
Timepoint [1] 441838 0
Baseline, 6 months, 12 months post-implantation
Secondary outcome [2] 441839 0
Left ventricular global longitudinal strain
Timepoint [2] 441839 0
Baseline, 6 months, 12 months post-implantation
Secondary outcome [3] 441840 0
Left ventricular mass
Timepoint [3] 441840 0
Baseline, 12 months post-implantation
Secondary outcome [4] 441841 0
Right ventricular systolic pressure
Timepoint [4] 441841 0
Baseline, 6 months, 12 months post-implantation
Secondary outcome [5] 441842 0
Symptom assessment- New York Heart Association (NYHA) classification
Timepoint [5] 441842 0
Baseline, 12 months post-implantation
Secondary outcome [6] 441843 0
Heart failure hospitalizations
Timepoint [6] 441843 0
6 months, 12 months post-implantation
Secondary outcome [7] 441844 0
Lead threshold
Timepoint [7] 441844 0
At implant, 6 months, 12 months post-implantation
Secondary outcome [8] 441845 0
Pacing burden
Timepoint [8] 441845 0
6 months, 12 months post-implantation
Secondary outcome [9] 441846 0
Loss of left bundle branch capture
Timepoint [9] 441846 0
6 months, 12 months post-implantation
Secondary outcome [10] 441848 0
Device related complications such as injury to valvular tissue/leaflet entrapment leading to regurgitation, cardiac perforation, pericardial effusion, cardiac tamponade necessitating pericardial tapping, vascular injury, wound hematoma/infection, lead dislodgment necessitating lead replacement
Timepoint [10] 441848 0
From the time of implant to discharge from hospital. Subsequently, evaluation for complications will be conducted only if the patient presents with symptoms that are clinically deemed to be associated with a device-related complication.
Secondary outcome [11] 441849 0
Incidence of atrial fibrillation of >30 seconds
Timepoint [11] 441849 0
6 months and 12 months post-implantation
Secondary outcome [12] 441852 0
Left atrial volume
Timepoint [12] 441852 0
Baseline and 12 months post-implantation
Secondary outcome [13] 441853 0
Quality of life
Timepoint [13] 441853 0
Baseline and 12 months post-implantation
Secondary outcome [14] 441854 0
QRS duration
Timepoint [14] 441854 0
Baseline, at implant and 12 months post-implantation
Secondary outcome [15] 442149 0
Left atrial strain
Timepoint [15] 442149 0
Baseline and 12 months post implant

Eligibility
Key inclusion criteria
1. Age: above 18 years
2. AV block or any other bradyarrhythmia with pacing burden of >40%
3. Left ventricular ejection fraction (LVEF) >35%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. LVEF <35%
2. Patients with biventricular pacing
3. Patients with structural heart disease
4. Patients with alternative pathology which can cause LV dysfunction, such as severe MR, severe AS or AR
5. Patients with atrial fibrillation
6. Patients for ‘pace and ablate’ therapy
7. Patients being considered for epicardial pacing
8. Patients refused to provide consent
9. Limited life expectancy due to comorbidity

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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
11/12/2023
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 317832 0
Other Collaborative groups
Name [1] 317832 0
Canberra heart rhythm foundation
Country [1] 317832 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Canberra heart rhythm
Address
Country
Australia
Secondary sponsor category [1] 320166 0
None
Name [1] 320166 0
Address [1] 320166 0
Country [1] 320166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316518 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316518 0
Ethics committee country [1] 316518 0
Australia
Date submitted for ethics approval [1] 316518 0
02/07/2021
Approval date [1] 316518 0
29/10/2021
Ethics approval number [1] 316518 0

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

Contacts
Principal investigator
Name 138138 0
Prof Rajeev K Pathak
Address 138138 0
Canberra heart rhythm, Suite 14, 2 Garran place, Garran, ACT
Country 138138 0
Australia
Phone 138138 0
+61 02 51122532
Fax 138138 0
Email 138138 0
rajeev.pathak@caberraheartrhythm.com.au
Contact person for public queries
Name 138139 0
Rajeev K Pathak
Address 138139 0
Canberra heart rhythm, Suite 14, 2 Garran place, Garran, ACT
Country 138139 0
Australia
Phone 138139 0
+61 02 51122532
Fax 138139 0
Email 138139 0
rajeev.pathak@caberraheartrhythm.com.au
Contact person for scientific queries
Name 138140 0
Rajeev K Pathak
Address 138140 0
Canberra heart rhythm, Suite 14, 2 Garran place, Garran, ACT
Country 138140 0
Australia
Phone 138140 0
+61 02 51122532
Fax 138140 0
Email 138140 0
rajeev.pathak@caberraheartrhythm.com.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 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.