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Recruiting NCT06540521

NCT06540521 Bolt CSP-M Holter Study

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Clinical Trial Summary
NCT ID NCT06540521
Status Recruiting
Phase
Sponsor Medtronic Cardiac Rhythm and Heart Failure
Condition Heart Failure
Study Type OBSERVATIONAL
Enrollment 75 participants
Start Date 2024-08-13
Primary Completion 2026-06-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
No intervention

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 75 participants in total. It began in 2024-08-13 with a primary completion date of 2026-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Simon Cao, PhD

✉ Simon.cao@medtronic.com

📞 862133230325

Frequently Asked Questions

Who can join the NCT06540521 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06540521 currently recruiting?

Yes, NCT06540521 is actively recruiting participants. Contact the research team at Simon.cao@medtronic.com for enrollment information.

Where is the NCT06540521 trial being conducted?

This trial is being conducted at Shanghai, China, Hangzhou, China.

Who is sponsoring the NCT06540521 clinical trial?

NCT06540521 is sponsored by Medtronic Cardiac Rhythm and Heart Failure. The trial plans to enroll 75 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology