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NCT Number: NCT06745778

Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:

• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.

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Key information

Conditions

Ventricular Tachycardia (VT) Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged >=18 yrs.
  • Patients indicated for ICD or CRT-D (primary or secondary prevention)
  • Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
  • Patients' EGM can be digitally recorded
  • Patients are willing to participate in the study and provide signed informed consent

Exclusion criteria

  • Patients received CIED upgrade or replacement with old pacing leads
  • Patients are pregnant
  • Patients participate in another study that will confound this study

Treatment and study plan

Primary outcomes

  1. R-wave amplitude of LBB EGM

    Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment

    Amplitude in millivolt

Secondary outcomes

  1. EGM morphology-LVAT

    Time frame: At the enrollment, 3 months after enrollment and 6 months after enrollment

    LVAT in millisecond, calculated based on electrogram recorded by LBB lead

Other outcomes

  1. echocardiography results-LVEF

    Time frame: At the enrollment and 6 months after enrollment

    LVEF in percentage

  2. echocardiography results-SV

    Time frame: At the enrollment and 6 months after enrollment

    SV in millilitre

  3. echocardiography results-LVEDV

    Time frame: At the enrollment and 6 months after enrollment

    LVEDV in millilitre

  4. echocardiography results-LVESV

    Time frame: At the enrollment and 6 months after enrollment

    LVESV in millilitre

  5. echocardiography results-LVEDD

    Time frame: At the enrollment and 6 months after enrollment

    LVEDD in millimetre

  6. echocardiography results-LVESD

    Time frame: At the enrollment and 6 months after enrollment

    LVESD in millimetre

Study contacts

Contact information is provided by the study sponsor or research team.

Simon Cao, Ph.D

CONTACT

[email protected]

862133230325

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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