Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing
Conditions
Keywords
pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy, bradycardiac arrhythmia
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
Interventions
Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region
DEVICEBi-ventricular pacing
Bi-ventricular pacing by a CRT/CRTD device
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Sir Run Run Shaw Hospital
The First Affiliated Hospital of Dalian Medical University
Shanxi Cardiovascular Hospital
Shanghai 10th People's Hospital
The Second Affiliated Hospital of Harbin Medical University
The First People's Hospital of Yunnan
Shanghai Zhongshan Hospital
Shenzhen Sun Yat-sen Cardiovascular Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Second Affiliated Hospital of Nanchang University
Tianjin Chest Hospital
Xiamen Cardiovascular Hospital, Xiamen University
Yan'an Affiliated Hospital of Kunming Medical University
Shanghai Chest Hospital
Medtronic (Shanghai) Management Co. Ltd.
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of LVEF | 12 months | To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| successful rate | 12 months | To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group. |
| mortality and heart failure hospitalization rate | 12 months | To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant |
| Change of LVESV | 12 months | To demonstrate and compare the LVESV at 12 month post-implant. |
| QRS width between LBBP and CRT | 12 months | To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant. |
| incidence and severity of tricuspid regurgitation | 12 months | To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant |
| occurrence of serious complication associated with LBBP procedure | 12 months | To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant. |
Countries
China
Contacts
Primary ContactWeijian Huang, MD
Backup ContactLan Su, MD
Outcome results
None listed