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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVSP-CRT | Experimental | Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy. |
|
| RVAP-CRT | Active Comparator | Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left ventricular septal pacing | Device | For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| paced QRSd duration. | QRS duration measurement after the procedure | 6 months |
| paced QRSd duration. | QRS duration measurement after the procedure |
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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:
8. Patients with a history of heart transplantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37211145 | Result | Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19. | |
| 36704478 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| right ventricular apical pacing | Device | For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT. |
|
| 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 |
| Result |
| Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022. |
| 33930549 | Result | Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28. |