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

NCT06745778 | Recruiting

• 1 other identifier: LBBP-ICD study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Tachycardia (VT); Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

• R-wave amplitude of LBB EGM

  Amplitude in millivolt

  At the enrollment, 3 months after enrollment and 6 months after enrollment

Secondary Outcomes (1)

• EGM morphology-LVAT

  At the enrollment, 3 months after enrollment and 6 months after enrollment

Other Outcomes (6)

• echocardiography results-LVEF

  At the enrollment and 6 months after enrollment

• echocardiography results-SV

  At the enrollment and 6 months after enrollment

• echocardiography results-LVEDV

  At the enrollment and 6 months after enrollment

Study Arms (1)

ICD or CRT-D patients who have received LBBP implantation

Patients' EGMs can be recorded by Holter DR220

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients received CIED upgrade or replacement with old pacing leads
• Patients are pregnant
• Patients participate in another study that will confound this study

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (2)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Shanghai Tongren Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36589004 RESULT

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simon Cao, Ph.D

CONTACT

862133230325; simon.cao@medtronic.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: February 26, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)