Evolution of Intracardiac Electrograms Recorded by Left Bundle Branch Pacing Lead in Patients With ICD or CRT-D

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Tongren Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Simon Cao, Ph.D
simon.cao@medtronic.com
862133230325
Time Frame
Start Date: 2025-02-26
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 50
Treatments
ICD or CRT-D patients who have received LBBP implantation
Patients' EGMs can be recorded by Holter DR220
Sponsors
Leads: Medtronic Cardiac Rhythm and Heart Failure

This content was sourced from clinicaltrials.gov