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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBP Treatment | Experimental | Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device |
|
| BVP Treatment | Active Comparator | Patients were performed bi-ventricular pacing by a CRT/CRTD device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of LVESV | To demonstrate and compare the LVESV at 12 month post-implant. | 12 months |
| successful rate | To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Huang, MD | Contact | +86138-0669-1086 | weijianhuang69@126.com | |
| Lan Su, MD | Contact | +86 137-3874-2616 | 2512057600@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Weijian Huang, MD | Wenzhou 1st Affliated Hopsital, Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affliated Hospital, Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| 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 |
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| Bi-ventricular pacing | Device | Bi-ventricular pacing by a CRT/CRTD device |
|
| 12 months |
| mortality and heart failure hospitalization rate | To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant | 12 months |
| occurrence of serious complication associated with LBBP procedure | To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant. | 12 months |
| QRS width between LBBP and CRT | 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. | 12 months |
| incidence and severity of tricuspid regurgitation | To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant | 12 months |
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| D009362 | Neoplasm Metastasis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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