Bolt CSP-M Holter Study

Recruiting now

Conditions studied: Heart Failure, Bradycardia

In brief

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.

Key facts

Study ID

NCT06540521

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

75

Starts

2024-08-13

Expected to finish

2026-06-30

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Zhejiang Greentown Cardiovascular Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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