Clinical trial NCT05553626: Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
Official title: Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Sir Run Run Shaw Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Shanxi Cardiovascular Hospital
name: Shanghai 10th People's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: The First People's Hospital of Yunnan
name: Shanghai Zhongshan Hospital
name: Shenzhen Sun Yat-sen Cardiovascular Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Second Affiliated Hospital of Nanchang University
name: Tianjin Chest Hospital
name: Xiamen Cardiovascular Hospital, Xiamen University
name: Yan'an Affiliated Hospital of Kunming Medical University
name: Shanghai Chest Hospital
name: Medtronic (Shanghai) Management Co. Ltd.
First posted: 2022-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of LVEF
timeFrame: 12 months
Secondary outcomes:
measure: Change of LVESV
timeFrame: 12 months
measure: successful rate
timeFrame: 12 months
measure: mortality and heart failure hospitalization rate
timeFrame: 12 months
measure: occurrence of serious complication associated with LBBP procedure
timeFrame: 12 months
measure: QRS width between LBBP and CRT
timeFrame: 12 months
measure: incidence and severity of tricuspid regurgitation
timeFrame: 12 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affliated Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
name: Weijian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: