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NCT Number: NCT06540521

Bolt CSP-M Holter Study

The purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in LBB area pacing (LBBAP), from which the findings may help to develop and support data validation of a novel algorithm for LBB capture determination for LBBAP.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China

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About this study

Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.

During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged >=18 years
  • Patients who are willing to provide Informed Consent
  • Patients who have received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month)
  • Patients implanted with a single/dual-chamber pacemaker or a CRT-P with LBBAP lead connected to RV port
  • Implanted device can provide at least 3-channel real-time intracardiac electrogram

Exclusion criteria

  • Patients who are pregnant or have a plan for pregnancy during the study
  • Patients who have medical conditions that would limit study participation
  • Patients who were already enrolled in clinical trial(s) which would impact study participation

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Intracardiac electrical characteristics in different pacing outputs.

    Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

    12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.

Secondary outcomes

  1. Intracardiac electrical characteristics under different body position.

    Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

    12-lead ECG and LBBAP EGM characteristics and duration under different body positions.

  2. The correlation between LBB capture status and LBBAP EGM characteristics

    Time frame: received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

    ECG and EGM characteristics in different LBB capture status

Study contacts

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

Simon Cao, PhD

CONTACT

[email protected]

862133230325

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Intracardiac Electrical Characteristics of LBBAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Sep 29, 2025

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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