Official Title
Intracardiac Electrical Characteristics of LBBAP
Brief Summary

The purpose of this study is to investigate the cardiac electrical characteristics indifferent pacing outputs and body positions in LBB area pacing (LBBAP), from which thefindings may help to develop and support data validation of a novel algorithm for LBBcapture determination for LBBAP.

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 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.

Recruiting
Heart Failure
Bradycardia

Other: No intervention

No intervention

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Shanghai Chest Hospital
Shanghai, Shanghai, China

Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang, China

Contacts

Simon Cao, PhD
862133230325
Simon.cao@medtronic.com

Not Provided

Medtronic Cardiac Rhythm and Heart Failure
NCT Number
Keywords
LBBAP
LBBP
LVSP
MeSH Terms
Bradycardia