About this trial
The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:
• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >=18 yrs.
Patients indicated for ICD or CRT-D (primary or secondary prevention)
Patients who recently (<=30 days) received ICD/CRT-D implantation with LBBP
Patients' EGM can be digitally recorded
Disqualifiers
Patients received CIED upgrade or replacement with old pacing leads
Patients are pregnant
Patients participate in another study that will confound this study
Trial population
The study selected two study site in China. One is a Tertiary A hospital in Zhejiang Province, and another is a hospital in Shanghai. Both of the two sites locate in south east of China. This study will enroll around 50 subjects who meet the inclusion and exclusion criteria from the ICD or CRT-D patients who have received LBBAP in the two hospitals.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
R-wave amplitude of LBB EGM
Amplitude in millivolt
Secondary outcomes
EGM morphology-LVAT
LVAT in millisecond, calculated based on electrogram recorded by LBB lead
Other outcomes
echocardiography results-LVEF
LVEF in percentage
echocardiography results-SV
SV in millilitre
echocardiography results-LVEDV
LVEDV in millilitre
echocardiography results-LVESV
LVESV in millilitre
Sponsors and contacts
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