LVSP Based CRT vs. RVAP Based CRT

Study Overview
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Brief Summary
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To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients with failed left bundle branch pacing at the beginning of chronic heart failure.

Official Title
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Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial

Conditions
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Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Septal Pacing, Right Ventricular Septal Pacing

Intervention / Treatment
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* Device: left ventricular septal pacing
* Device: right ventricular apical pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5. Signed the informed consent form for the study. Exclusion Criteria: Previous mechanical tricuspid valve replacement. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%. Patients participated in any of the other studies at the same time, which may confound the results of this study. Pregnancy, planning to become pregnant. 8. Patients with a history of heart transplantation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVSP-CRT<br>Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy. | Device: left ventricular septal pacing<br>* For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.<br>|
| Active Comparator: RVAP-CRT<br>Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy. | Device: right ventricular apical pacing<br>* For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction (LVEF) | LVEF evaluated by echocardiography，Bi-plane Simpson's method | 6 months | 
| left ventricular ejection fraction (LVEF) | LVEF evaluated by echocardiography，Bi-plane Simpson's method | 12 months | 
| left ventricular end-systolic volume (LVESV) | LVESV evaluated by echocardiography | 6 months | 
| left ventricular end-systolic volume (LVESV) | LVESV evaluated by echocardiography | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| paced QRSd duration. | QRS duration measurement after the procedure | 6 months | 
| paced QRSd duration. | QRS duration measurement after the procedure | 12 months | 
| NT-proBNP | Serum NT-proBNP level | 6 months | 
| NT-proBNP | Serum NT-proBNP level | 12 months | 
| 6-minute hall walk distance | 6-minute hall walk distance | 6 months | 
| 6-minute hall walk distance | 6-minute hall walk distance | 12 months | 
| Heart failure rehospitalization | Rehospitalization due to the exacerbation of heart failure | 6 months | 
| Heart failure rehospitalization | Rehospitalization due to the exacerbation of heart failure | 12 months | 
| Rehospitalization for cardiovascular adverse events | Rehospitalization for cardiovascular adverse events | 12 months | 
| Malignant ventricular arrhythmias | ICD therapy for ventricular tachycardia or ventricular fibrillation | 6 months | 
| Malignant ventricular arrhythmias | ICD therapy for ventricular tachycardia or ventricular fibrillation | 12 months | 
| All cause death | All cause death events | 6 months | 
| All cause death | All cause death events | 12 months |