Cardiac Resynchronization Therapy, Heart Failure, Left Ventricular Septal Pacing, Right Ventricular Septal Pacing
Conditions
Brief summary
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.
Interventions
For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.
For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.
Sponsors
Fu Wai Hospital, Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
1. Previous mechanical tricuspid valve replacement. 2. Previous pacemaker or other devices implanted and for device replacement or upgrading for this time. 3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI surgery within three months. 4. Persistent atrial fibrillation without AV block, the proportion of biventricular pacing is not expected to less than 95%. 5. Patients participated in any of the other studies at the same time, which may confound the results of this study. 6. Pregnancy, planning to become pregnant. 8\. Patients with a history of heart transplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular ejection fraction (LVEF) | 6 months | LVEF evaluated by echocardiography，Bi-plane Simpson's method |
| left ventricular end-systolic volume (LVESV) | 6 months | LVESV evaluated by echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute hall walk distance | 6 months | 6-minute hall walk distance |
| Heart failure rehospitalization | 6 months | Rehospitalization due to the exacerbation of heart failure |
| paced QRSd duration. | 6 months | QRS duration measurement after the procedure |
| Malignant ventricular arrhythmias | 6 months | ICD therapy for ventricular tachycardia or ventricular fibrillation |
| All cause death | 6 months | All cause death events |
| Rehospitalization for cardiovascular adverse events | 12 months | Rehospitalization for cardiovascular adverse events |
| NT-proBNP | 6 months | Serum NT-proBNP level |
Countries
China
Outcome results
None listed