Actively Recruiting

Age: 18Years +
All Genders
NCT06540521

Bolt CSP-M Holter Study

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

75

Participants Needed

2

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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