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

Heart Failure Bradycardia

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

Inclusion Criteria5

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 Criteria3

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