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Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block

NCT05553626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-09-23

No results posted yet for this study

Summary

This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF \<50% and the estimated ventricular pacing percentage \>40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis

Conditions

  • Atrioventricular Block, Second and Third Degree
  • Heart Failure
  • Left Bundle Branch Pacing

Interventions

DEVICE

Left bundle branch pacing

Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region

DEVICE

Bi-ventricular pacing

Bi-ventricular pacing by a CRT/CRTD device

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER

  • Shanxi Cardiovascular Hospital

    collaborator OTHER

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • The First People's Hospital of Yunnan

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Shenzhen Sun Yat-sen Cardiovascular Hospital

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Tianjin Chest Hospital

    collaborator OTHER

  • Xiamen Cardiovascular Hospital, Xiamen University

    collaborator OTHER

  • Yan'an Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Shanghai Chest Hospital

    collaborator OTHER

  • Medtronic (Shanghai) Management Co. Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Weijian Huang, MD · Wenzhou 1st Affliated Hopsital, Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-02-29
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553626 on ClinicalTrials.gov