Status:
RECRUITING
Bolt CSP-M Holter Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Bradycardia
Eligibility:
All Genders
18+ years
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 develo...
Detailed Description
Among LBB area pacing (LBBAP), it has been reported that left ventricular (LV) septal pacing (LVSP), which refers to a pacing approach that only captures the LV septal myocardium, produces homogeneous...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06540521
Start Date
August 13 2024
End Date
June 30 2026
Last Update
September 29 2025
Active Locations (2)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
2
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang, China