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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
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This is a multicenter, randomized controlled study. This study aims to compare the clinical efficacy of LBBAP with traditional biventricular pacing in patients with permanent atrial fibrillation and heart Failure
LBBAP-AFHF is a prospective, multicenter, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may show superiority of improved LV function as compared with traditional biventricular pacing (BiVP) in patients with permanent atrial fibrillation and heart failure (LVEF<50%) who receive atrioventricular nodal ablation due to fast ventricular rate or require high percentage of ventricular pacing due to slow ventricular rate. The primary endpoint of this trial is the change in the LVEF at 6 months after device implantation from baseline. A CRT-P/D device would be implanted and LBBAP lead would be connected to the RA port and LV lead to the LV port. Patients who receive successful LBBAP and BiVP simultaneously during the procedure would be 1:1 randomized to LBBAP or BiVP group after the procedure by device programming. Patients will be followed at 3 and 6 months post-discharge for LVEF and other echographic parameters (including LVESV, response rate), and rehospitalization for heart failure or all-cause death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBAP group | Experimental | Device: Left bundle branch area pacing(LBBAP) LBBAP is a novel physiological pacing form for ventricular pacing. In patients who received LBBAP, the pacing lead will be placed at the left bundle branch area to achieve a narrow-paced QRS duration. |
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| BiVP group | Active Comparator | Device: Biventricular pacing (BiVP) Biventricular pacing is the traditional pacing modality for patients with heart failure. For BiVP, one pacing lead was placed in the coronary sinus, named LV lead, and another lead was placed in the right ventricule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left bundle branch area pacing | Device | Left bundle branch area pacing is a novel physiological pacing modality and is reported to be feasible and safe in patients with heart failure and left bundle branch block. |
| Measure | Description | Time Frame |
|---|---|---|
| ΔLVEF between baseline and six months post-discharge | ΔLVEF：change in LVEF between baseline and six months after procedure | Six months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| The immediate success rate of the LBBAP procedure | Successful LBBAP procedure is identified according to ECG and intracardiac ECG electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP). | 1 weeks |
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Inclusion Criteria:
Adult patients aged more than 18 years old
Patients diagnosed with heart failure (LVEF<50%) and have received optimal medical therapy for at least 3 months
Patients with permanent atrial fibrillation (QRS duration <130ms) which need ventricular pacing, including:
Written informed consent was provided
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haojie Zhu, M.D | Contact | +8613167310573 | 13167310573@163.com | |
| Xiaofei Li, M.D | Contact | +8617801013995 | lixiaofei0103@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohan Fan, PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| Peking University First Hospital | OTHER |
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| Biventricular pacing | Device | Biventricular pacing is a widely-established modality to treat heart failure in patients with heart failure |
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| The rate of procedure and Device related complications | Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications | 6 months |
| ΔLVEDD between baseline and six months post-discharge | ΔLVEDD：change in LVEDD between baseline and six months after procedure between two groups | 6 months |
| ΔLVEDV between baseline and six months post-discharge | ΔLVEDV：change in LVEDV between baseline and six months after procedure between two groups | 6 months |
| The echocardiographic response rate of LVEF increase ≥5% | the percentage of patients with change of LVEF ≥5% at 6 month from baseline | 6 months |
| The changes of NT-proBNP betwen baseline and 6 months post-discharge | The changes of NT-proBNP betwen baseline and 6 months post-discharge | 6 months |
| Composite incidence rate of all-cause mortality and/or hospitalization for heart failure | All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy. | 6 months |
| The echocardiographic response rate of LVEF increase ≥15% | an increase in LVESV ≥15% during follow-up at 6 month compared with baseline | 6 months |
| The rate of ΔLVESV ≥15% between baseline and six months post-discharge | the percentage of patients with change of ΔLVESV ≥15% at 6 month from baseline | 6 months |
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100037 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Second Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The first affiliated hospital of Nanjing medical university | Not yet recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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