Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LBBP Treatment Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device |
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
|
| Active Comparator: BVP Treatment Patients were performed bi-ventricular pacing by a CRT/CRTD device |
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Change of LVESV [12 months]
To demonstrate and compare the LVESV at 12 month post-implant.
- 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
- 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.
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affliated Hospital, Wenzhou Medical University | Wenzhou | Zhejiang | China | 325000 |
Sponsors and Collaborators
- First Affiliated Hospital of Wenzhou Medical University
- 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.
Investigators
- Principal Investigator: Weijian Huang, MD, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FirstWenzhouMU216-02