Bolt CSP-M Holter Study

NCT06540521 | Recruiting

• 1 other identifier: MDT24030
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; Bradycardia

Keywords

LBBAP; LBBP; LVSP

Outcome Measures

Primary Outcomes (1)

• Intracardiac electrical characteristics in different pacing outputs.

  12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.

  received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

Secondary Outcomes (2)

• Intracardiac electrical characteristics under different body position.

  received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

• The correlation between LBB capture status and LBBAP EGM characteristics

  received LBBAP therapy >= 1 month for 1 to 4 months (including 1 and 4 month); and an optional follow-up 6 month after the enrollment

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study selected two study site in China. One is a Tertiary A hospital in Shanghai, and another is a cardiovascular specialty hospital in Zhejiang Province. Both the two sites locate in the south east of China. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the patients who have received LBBAP therapies from the two hospitals.

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Related Publications (4)

• Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.

  PMID: 29173611 BACKGROUND

• Chen X, Qian Z, Zou F, Wang Y, Zhang X, Qiu Y, Hou X, Zhou X, Vijayaraman P, Zou J. Differentiating left bundle branch pacing and left ventricular septal pacing: An algorithm based on intracardiac electrophysiology. J Cardiovasc Electrophysiol. 2022 Mar;33(3):448-457. doi: 10.1111/jce.15350. Epub 2022 Jan 12.

  PMID: 34978368 BACKGROUND

• Zhou Y, Wang J, Wei Y, Zhang W, Yang Y, Rui S, Ju C. Left ventricular septal pacing versus left bundle branch pacing in the treatment of atrioventricular block. Ann Noninvasive Electrocardiol. 2022 May;27(3):e12944. doi: 10.1111/anec.12944. Epub 2022 Mar 10.

  PMID: 35267228 BACKGROUND

• Wu S, Chen X, Wang S, Xu L, Xiao F, Huang Z, Zheng R, Jiang L, Vijayaraman P, Sharma PS, Su L, Huang W. Evaluation of the Criteria to Distinguish Left Bundle Branch Pacing From Left Ventricular Septal Pacing. JACC Clin Electrophysiol. 2021 Sep;7(9):1166-1177. doi: 10.1016/j.jacep.2021.02.018. Epub 2021 Apr 28.

  PMID: 33933414 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simon Cao, PhD

CONTACT

862133230325; Simon.cao@medtronic.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)