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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000428561
Enrollment
28
Registered
2024-04-08
Start date
2024-04-09
Completion date
2024-08-10
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Dr. Rajeev Kumar Pathak
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026