Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000428561
Ethics application status
Approved
Date submitted
13/02/2024
Date registered
8/04/2024
Date last updated
8/04/2024
Date data sharing statement initially provided
8/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of correlation between differences in ventricular activation and degree of response to left bundle branch area pacing and biventricular pacing cardiac resynchronization therapy
Scientific title
A study of correlation between differences in ventricular activation and degree of response to left bundle branch area pacing and biventricular pacing cardiac resynchronization therapy in heart failure patients
Secondary ID [1] 311539 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 332894 0
Condition category
Condition code
Cardiovascular 329611 329611 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Heart failure patients who received biventricular pacing or left bundle pacing cardiac resynchronization therapy >1 year before will be included in the study. Only super-responders and non-responders who provide their informed consent will be included in the study. Non-invasive epicardial mapping of cardiac activation pattern will be done for all patients with Medtronic’s Cardioinsight technology.
Observational assessment will be completed in 30-60 min time period in clinic set up.
Observation will only be done once and the measurements will then be compared.
If deemed necessary, endocardial mapping of biventricular activation will be done in cardiac electrophysiology laboratory. Octaray mapping catheter will be used for endocardial mapping.
Intervention code [1] 327997 0
Not applicable
Comparator / control treatment
Biventricular pacing arm will be reference comparator cohort.
Control group
Active

Outcomes
Primary outcome [1] 337399 0
eDYS – time difference between the earliest and latest activation site
Timepoint [1] 337399 0
At the time of cardiac mapping
Secondary outcome [1] 431675 0
Global right/left ventricular electrical synchrony: the difference between mean RV and LV activation times
Timepoint [1] 431675 0
At the time of cardiac mapping
Secondary outcome [2] 431676 0
Global biventricular total activation time
Timepoint [2] 431676 0
At the time of cardiac mapping
Secondary outcome [3] 431677 0
Global LV activation time
Timepoint [3] 431677 0
At the time of cardiac mapping

Eligibility
Key inclusion criteria
1. Patients with LBBB, QRS 130 ms or greater and HF who had LVEF 35% or less at baseline.
2. Received either BiV or LBBAP CRT.
3. Super-responders: Those who demonstrated 20% or more improvement in LVEF at 12 months post-procedure.
4. Non-responders: Those who demonstrated less than 10% in LVEF at 12 months post-procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with dyssynchrony other than LBBB and/or QRS <130 ms at baseline
2. Patients with LVEF >35% at baseline
3. Patients with intermediate (10-19%) improvement in LVEF at 12 months post-procedure.
4. Refuse to/unable to give consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2024
Actual
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
15/05/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 315836 0
Commercial sector/Industry
Name [1] 315836 0
Medtronic
Country [1] 315836 0
United States of America
Primary sponsor type
Individual
Name
Dr. Rajeev Kumar Pathak
Address
Country
Australia
Secondary sponsor category [1] 317964 0
None
Name [1] 317964 0
Address [1] 317964 0
Country [1] 317964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314691 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 314691 0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Ethics committee country [1] 314691 0
Australia
Date submitted for ethics approval [1] 314691 0
25/01/2024
Approval date [1] 314691 0
26/02/2024
Ethics approval number [1] 314691 0

Summary
Brief summary
Approximately 30%-40% patients do not respond to biventricular (BiV) pacing for cardiac resynchronisation therapy (CRT). Response to left bundle branch area pacing (LBBAP) also appears to be variable and ranges from no response to super-response. Whether differences in LV activation is responsible for this variable response is unclear. In this study, we aim to evaluate differences ventricular activation in patients with super-response and non-response to LBBAP and BiV-CRT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132410 0
A/Prof Rajeev Kumar Pathak
Address 132410 0
Canberra Heart Rhythm, Suite 14, 2 Garran Place, Garran, ACT - 2605
Country 132410 0
Australia
Phone 132410 0
+61477653949
Fax 132410 0
Email 132410 0
rajeev.pathak@canberraheartrhythm.com.au
Contact person for public queries
Name 132411 0
Rajeev Kumar Pathak
Address 132411 0
Canberra Heart Rhythm, Suite 14, 2 Garran Place, Garran, ACT - 2605
Country 132411 0
Australia
Phone 132411 0
+61477653949
Fax 132411 0
Email 132411 0
rajeev.pathak@canberraheartrhythm.com.au
Contact person for scientific queries
Name 132412 0
Rajeev Kumar Pathak
Address 132412 0
Canberra Heart Rhythm, Suite 14, 2 Garran Place, Garran, ACT - 2605
Country 132412 0
Australia
Phone 132412 0
+61477653949
Fax 132412 0
Email 132412 0
rajeev.pathak@canberraheartrhythm.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21639Study protocol  Jenish.shroff@canberraheartrhythm.com.au 387338-(Uploaded-06-04-2024-09-34-59)-Study-related document.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.