No intervention
OtherNo intervention
NCT Number: NCT06540521
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China
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 electrical propagation in the septum and leads to delayed LV lateral wall activation. Although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the LBB capture over LVSP.
During the implantation of a device, the most commonly used method to distinguish LVSP from the LBB capture is to pace with different pacing outputs. A transition will be found in the ECG morphology with changes in the LV activation time if the pacing capture threshold (PCT) of the local myocardium is different from that of the LBB (i.e., LBB-PCT), indicating a transition between capturing the LBB and LVSP without any LBB capture. So far, there is no systematic investigation on the EGM characteristics or correlation between ECG and EGM characteristics at different conduction system capture status. Findings from this study will help to better characterize EGM characteristics and to develop an optimal LBBAP modality to differentiate LBB capture.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Time frame: 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
12-lead ECG and LBBAP EGM characteristics and duration in different pacing outputs.
Time frame: 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
12-lead ECG and LBBAP EGM characteristics and duration under different body positions.
Time frame: 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
ECG and EGM characteristics in different LBB capture status
Contact information is provided by the study sponsor or research team.
Medtronic Cardiac Rhythm and Heart Failure
Industry
Intracardiac Electrical Characteristics of LBBAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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