RecruitingNCT06540521

Bolt CSP-M Holter Study

Intracardiac Electrical Characteristics of LBBAP


Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Enrollment

75 participants

Start Date

Aug 13, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable cardiac monitor (the Bolt CSP-M Holter device) in people who have recently had a special type of pacemaker lead placed in their heart's left bundle branch area (called LBBAP). The goal is to assess whether this external monitor can accurately record the heart's electrical signals and capture data useful for adjusting the pacemaker settings. **You may be eligible if...** - You are 18 or older - You received LBBAP pacemaker therapy 1 to 4 months ago - Your pacemaker is a single- or dual-chamber device or a cardiac resynchronization therapy pacemaker with the lead connected to the right ventricle port - Your device can provide at least 3 channels of real-time heart electrical recordings **You may NOT be eligible if...** - You are pregnant or planning to become pregnant during the study - You have medical conditions that would limit participation - You are already enrolled in another clinical trial that conflicts with this one Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention


Locations(2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, China

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NCT06540521


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