Ventricular Fibrillation, Ventricular Tachycardia (VT)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Patients are willing to participate in the study and provide signed informed consent
Exclusion criteria
* Patients received CIED upgrade or replacement with old pacing leads * Patients are pregnant * Patients participate in another study that will confound this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R-wave amplitude of LBB EGM | At the enrollment, 3 months after enrollment and 6 months after enrollment | Amplitude in millivolt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EGM morphology-LVAT | At the enrollment, 3 months after enrollment and 6 months after enrollment | LVAT in millisecond, calculated based on electrogram recorded by LBB lead |
Countries
China
Contacts
CONTACTSimon Cao, Ph.D
Outcome results
None listed