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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia (VT)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Simon Cao, Ph.D; Phone Number: 862133230325; Email: simon.cao@medtronic.com

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Shanghai Tongren Hospital
    • Contact: Zhaohui Qiu, MD; Phone Number: +86-21-52039999; Email: qzh3503@shtrhospital.com
    • Principal Investigator: Zhaohui Qiu, MD
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Principal Investigator: Weijian Huang, MD
      • Contact: Weijian Huang, MD; Phone Number: +86-577-55579591; Email: weijianhuang69@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICD or CRT-D patients who have received LBBP implantation; Patients' EGMs can be recorded by Holter DR220

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R-wave amplitude of LBB EGM	Amplitude in millivolt	At the enrollment, 3 months after enrollment and 6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EGM morphology-LVAT	LVAT in millisecond, calculated based on electrogram recorded by LBB lead	At the enrollment, 3 months after enrollment and 6 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
echocardiography results-LVEF	LVEF in percentage	At the enrollment and 6 months after enrollment
echocardiography results-SV	SV in millilitre	At the enrollment and 6 months after enrollment
echocardiography results-LVEDV	LVEDV in millilitre	At the enrollment and 6 months after enrollment
echocardiography results-LVESV	LVESV in millilitre	At the enrollment and 6 months after enrollment
echocardiography results-LVEDD	LVEDD in millimetre	At the enrollment and 6 months after enrollment
echocardiography results-LVESD	LVESD in millimetre	At the enrollment and 6 months after enrollment

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Ventricular Fibrillation
• Other Study ID Numbers: LBBP-ICD study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No