Actively Recruiting

Age: 18Years +
All Genders
ID06540521

Intracardiac Electrical Characteristics of Left Bundle Branch Area Pacing in Heart Failure and Bradycardia

Led by Medtronic Cardiac Rhythm and Heart Failure · Updated on 2025-09-29

75

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the electrical features of the heart during different pacing outputs and body positions in left bundle branch area pacing (LBBAP). This study aims to help develop and validate a new algorithm to better identify left bundle branch (LBB) capture during LBBAP, which may improve understanding of heart pacing effects. The study focuses on patients with heart failure or bradycardia who have received LBBAP therapy. The study observes patients who have had LBBAP therapy for 1 to 4 months and have devices capable of providing real-time intracardiac electrograms. There is no active treatment or intervention involved. The study monitors electrical characteristics under various pacing outputs and body positions, aiming to differentiate between LBB capture and left ventricular septal pacing (LVSP). Participants will be followed from 1 month up to 4 months after receiving LBBAP therapy, with an optional follow-up at 6 months after enrollment. During this time, researchers will collect data on intracardiac electrical signals and their correlation with ECG findings. No additional treatments are given; the study focuses on collecting and analyzing heart electrical activity to understand pacing effects and improve pacing methods.

CONDITIONS

Brief Title

Bolt CSP-M Holter Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years
  • Patients willing to provide informed consent
  • Patients who have received LBBAP therapy for 1 to 4 months (including 1 and 4 months)
  • Patients implanted with a single-chamber, dual-chamber pacemaker, or CRT-P with LBBAP lead connected to the right ventricle port
  • Implanted device capable of providing at least 3-channel real-time intracardiac electrograms
Not Eligible

You will not qualify if you...

  • Patients who are pregnant or planning pregnancy during the study
  • Patients with medical conditions that would limit study participation
  • Patients already enrolled in clinical trials that could impact participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - 1 to 4 months

Participants who have received LBBAP therapy for 1 to 4 months are observed to assess intracardiac electrical characteristics under different pacing outputs and body positions.

1 to 4 visits depending on duration

Long-term Monitoring

Duration - Up to 6 months after enrollment

Optional follow-up visit approximately 6 months after enrollment to evaluate ongoing intracardiac electrical characteristics and correlation with LBB capture status.

1 follow-up visit (in-person)

Trial Site Locations

Total: 2 locations

1

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

2

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, China

Not Yet Recruiting

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Research Team

S

Simon Cao, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology.

Xing Chen, Zhiyong Qian, Fengwei Zou...

https://pubmed.ncbi.nlm.nih.gov/34978368