Clinical trial NCT06745778: Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
Official title: Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Tachycardia (VT)
Ventricular Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: R-wave amplitude of LBB EGM
timeFrame: At the enrollment, 3 months after enrollment and 6 months after enrollment
Secondary outcomes:
measure: EGM morphology-LVAT
timeFrame: At the enrollment, 3 months after enrollment and 6 months after enrollment
Other outcomes:
measure: echocardiography results-LVEF
timeFrame: At the enrollment and 6 months after enrollment
measure: echocardiography results-SV
timeFrame: At the enrollment and 6 months after enrollment
measure: echocardiography results-LVEDV
timeFrame: At the enrollment and 6 months after enrollment
measure: echocardiography results-LVESV
timeFrame: At the enrollment and 6 months after enrollment
measure: echocardiography results-LVEDD
timeFrame: At the enrollment and 6 months after enrollment
measure: echocardiography results-LVESD
timeFrame: At the enrollment and 6 months after enrollment
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
Study officials:
References:
citation: Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec.