Image Location and Performance of Left Bundle Branch Pacing

NCT04119323 | Completed

• 1 other identifier: IMAGE-LBBP study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing lead during LBBP.

Conditions

Cardiac Pacing; Pacing Therapy

Outcome Measures

Primary Outcomes (1)

• QRS duration

  The primary endpoint is QRS duration and morphology during LBBP

  at least 3 months after implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients indicated for LBBP and implanted with pacing lead for LBBP.

You may qualify if:

• Aged from 18 to 80 years old;
• Patients providing signed Informed Consent;
• Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records;
• Patients who plan to receive cardiac CT examination.

You may not qualify if:

• Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination;
• Patients who are pregnant or have a plan for pregnancy during the study;
• Patients who are not willing to provide Informed Consent;
• Patients who have medical conditions that would limit study participation;
• Patients who were already enrolled in other clinical trial which would impact his/her participation.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (3)

Fuwai Hospital

Beijing, Beijing Municipality, 010, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 025, China

Location

West China Hospital

Chengdu, Sichuan, 028, China

Location

Related Publications (2)

• Cai M, Qiu Y, Xu Y, Lu H, Chen Z, Hou X, Jiang L, Zhou X, Dai Y, Liu X, Zou J, Chen K. Distance From Pacing Lead Tip to Left Ventricular Cavity Predicts Long-term Loss of Left Bundle Branch Capture: Insights From the IMAGE-LBBP Cohort. Can J Cardiol. 2025 Nov 1:S0828-282X(25)01291-7. doi: 10.1016/j.cjca.2025.10.032. Online ahead of print.

  PMID: 41177376 DERIVED

• Zou J, Chen K, Liu X, Xu Y, Jiang L, Dai Y, Lin J, Hou X, Qiu Y, Himes A, Lucas R, Demmer W, Mara N, Zhou X, Lu H. Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):718-725. doi: 10.1111/jce.15843. Epub 2023 Feb 14.

  PMID: 36738153 DERIVED

Study Officials

• Xiaohong Zhou, M.D.

  Medtronic

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 8, 2019
• Study Start: September 24, 2019
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Locations

CN (3)