Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
NCT ID: NCT05553626
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2022-09-30
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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LBBP Treatment
Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD 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
Bi-ventricular pacing
Bi-ventricular pacing by a CRT/CRTD device
BVP Treatment
Patients were performed bi-ventricular pacing by a CRT/CRTD 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
Bi-ventricular pacing
Bi-ventricular pacing by a CRT/CRTD device
Interventions
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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
Bi-ventricular pacing
Bi-ventricular pacing by a CRT/CRTD device
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Sir Run Run Shaw Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Shanxi Cardiovascular Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
The First People's Hospital of Yunnan
OTHER
Shanghai Zhongshan Hospital
OTHER
Shenzhen Sun Yat-sen Cardiovascular Hospital
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Tianjin Chest Hospital
OTHER
Xiamen Cardiovascular Hospital, Xiamen University
OTHER
Yan'an Affiliated Hospital of Kunming Medical University
OTHER
Shanghai Chest Hospital
OTHER
Medtronic (Shanghai) Management Co. Ltd.
INDUSTRY
First Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Weijian Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
Locations
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First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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FirstWenzhouMU216-02
Identifier Type: -
Identifier Source: org_study_id
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