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

NCT05553626 | Unknown DMC

• 1 other identifier: FirstWenzhouMU216-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pacing induced cardiomyopathy; heart failure; pacing; LBBP; BVP; RVP; conduction system pacing; cardiac Resynchronization Therapy; bradycardiac arrhythmia

Outcome Measures

Primary Outcomes (1)

• Change of LVEF

  To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.

  12 months

Secondary Outcomes (6)

• Change of LVESV

  12 months

• successful rate

  12 months

• mortality and heart failure hospitalization rate

  12 months

• occurrence of serious complication associated with LBBP procedure

  12 months

• QRS width between LBBP and CRT

  12 months

Study Arms (2)

LBBP Treatment

EXPERIMENTAL

Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device

Device: Left bundle branch pacing; Device: Bi-ventricular pacing

BVP Treatment

ACTIVE COMPARATOR

Patients were performed bi-ventricular pacing by a CRT/CRTD device

Device: Left bundle branch pacing; Device: Bi-ventricular pacing

Interventions

Left bundle branch pacing DEVICE

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

BVP Treatment; LBBP Treatment

Bi-ventricular pacing DEVICE

Bi-ventricular pacing by a CRT/CRTD device

BVP Treatment; LBBP Treatment

Eligibility Criteria

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

You may qualify if:

• Above 18 years old
• Agree to participate in trial and sign informed consent
• NYHA cardiac function class I-III
• LVEF\<50%
• Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage \>40%
• Patients who are willing to take the de-novo implant or device replacement or upgrade.

You may not qualify if:

• Life expectancy \<1 year
• Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
• Acute myocardial infarction within 1 month
• Women of childbearing age who are pregnant or becoming pregnant during the study period
• Severe liver and kidney dysfunction2
• Have been enrolled in another clinical studies that may interferes with the current trial objectives
• Evidence of severe pulmonary hypertension (PASP\>70mmHg)
• Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
• The investigator believes that subject's physical condition is not suitable for participation in the trial

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Shanxi Cardiovascular Hospital: collaborator
• Shanghai 10th People's Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• The First People's Hospital of Yunnan: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Shenzhen Sun Yat-sen Cardiovascular Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Tianjin Chest Hospital: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• Yan'an Affiliated Hospital of Kunming Medical University: collaborator
• Shanghai Chest Hospital: collaborator
• Medtronic (Shanghai) Management Co. Ltd.: collaborator

Study Sites (1)

First Affliated Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Atrioventricular Block; Neoplasm Metastasis; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Weijian Huang, MD

  Wenzhou 1st Affliated Hopsital, Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weijian Huang, MD

CONTACT

+86138-0669-1086; weijianhuang69@126.com

Lan Su, MD

CONTACT

+86 137-3874-2616; 2512057600@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: September 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: September 23, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)