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| Name | Class |
|---|---|
| Beijing Anzhen Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.
LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected >40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBBAP group | Experimental | AV block patients randomized to left bundle branch area pacing |
|
| RVP group | Active Comparator | AV block patients randomized to right ventricular pacing group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left bundle branch area pacing | Device | Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced 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. Upgrade to cardiac resynchronization therapy (CRT): Upgrade from dual-chamber pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less). | Within two years after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of the composite outcomes of all-cause death 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-existing heart disease based primary outcome | All-cause death and/or hospitalization for heart failure comparison based on pre-exsiting heart disease (e.g. coronary heart disease, atrial fibirllation, valvular heart disease, and dilated cardiomyopathy. | Within 2 years after device implantation |
| Baseline QRSd based primary outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaohan Fan, PhD. | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen hospital, Capital Medical University | Beijing | Beijing Municipality | 100029 | China | ||
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19915220 | Background | Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15. | |
| 29274474 | Background | Vijayaraman P, Naperkowski A, Subzposh FA, Abdelrahman M, Sharma PS, Oren JW, Dandamudi G, Ellenbogen KA. Permanent His-bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm. 2018 May;15(5):696-702. doi: 10.1016/j.hrthm.2017.12.022. Epub 2017 Dec 20. |
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| Chinese Academy of Medical Sciences, Fuwai Hospital |
| OTHER |
| Tianjin Medical University General Hospital | OTHER |
| TEDA International Cardiovascular Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Chinese Society of Cardiology | OTHER |
| Affiliated Hospital of Qinghai University | OTHER |
| Shanxi Cardiovascular Hospital | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Peking University First Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Wuxi People's Hospital | OTHER |
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| Right ventricular pacing | Device | Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle. |
|
| Within 2 years after device implantation |
| Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. | 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. Upgrade to cardiac resynchronization therapy: Upgrade from dual chamber pacemaker to CRT-P/CRT-D due to impaired LV function (LVEF decrease to 40% or less). | Within 2 years after device implantation |
| Rate of the composite outcomes of LVEF <50%, and/or an increase in LVESV ≥15% during follow-up as compared with the value at randomization | Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and/or the LVESV is increased by 15% or more. | Within 2 years after device implantation |
| The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up | Echocardiography will be assessed at 1-year, and 2-year follow-up and the absolute value of LVEF and LVESV will be compared between two groups. | 24 months |
| The time to a first event of LVEF <50% and decrease in LVEF by ≥ 10% during 2 years follow-up as compared with the value at randomization. | Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and decreased by 15% or more as compared with the value at randomization. | 24 months |
| The immediate success rate of the LBBAP procedure | Successful LBBAP procedure is identified according to ECG and intracardiac 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 |
| The rate of procedure and Device related complications | Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications. | 24 months |
| Changes in Pacing parameters and ECG characteristics. | Pacing parameters include pacing thresholds (ventricle), Sense ampitude (ventricle), Impedance (ventricle). ECG characteristics include paced QRS duration and QRS morphology, etc. | 24 months |
| The occurrence of LV dyssynchrony | The occurrence of LV dyssynchrony will be evaluated by echocardiography during 2-year follow-up. | 24 months |
| Atrial high-rate episodes recorded by the pacemaker | Atrial high-rate episodes recorded in the pacemaker will be followed during two years of follow-up | 24 months |
| The long-term success rate of LBBAP | In LBBAP group, the successful LBBAP will be identified according ECG features at 2-years follow-up | 24 months |
All-cause death and/or hospitalization for heart failure comparison based on baseline QRSd (>120ms vs. ≤120ms) |
| Within 2 years after device implantation |
| Beijing |
| Beijing Municipality |
| 100037 |
| China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Teda International Cardiovascular Hospital | Tianjin | Tianjin Municipality | China |
| 30734436 | Background | Cho SW, Gwag HB, Hwang JK, Chun KJ, Park KM, On YK, Kim JS, Park SJ. Clinical features, predictors, and long-term prognosis of pacing-induced cardiomyopathy. Eur J Heart Fail. 2019 May;21(5):643-651. doi: 10.1002/ejhf.1427. Epub 2019 Feb 8. |
| 31504437 | Background | Tayal B, Fruelund P, Sogaard P, Riahi S, Polcwiartek C, Atwater BD, Gislason G, Risum N, Torp-Pedersen C, Kober L, Kragholm KH. Incidence of heart failure after pacemaker implantation: a nationwide Danish Registry-based follow-up study. Eur Heart J. 2019 Nov 21;40(44):3641-3648. doi: 10.1093/eurheartj/ehz584. |
| 30093543 | Background | Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Mao G, Vijayaraman P, Ellenbogen KA. Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019 Jan;105(2):137-143. doi: 10.1136/heartjnl-2018-313415. Epub 2018 Aug 9. |
| 29535066 | Background | Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10. |
| 27457727 | Background | Vijayaraman P, Dandamudi G. Anatomical approach to permanent His bundle pacing: Optimizing His bundle capture. J Electrocardiol. 2016 Sep-Oct;49(5):649-57. doi: 10.1016/j.jelectrocard.2016.07.003. Epub 2016 Jul 11. |
| 31048065 | Background | Li X, Li H, Ma W, Ning X, Liang E, Pang K, Yao Y, Hua W, Zhang S, Fan X. Permanent left bundle branch area pacing for atrioventricular block: Feasibility, safety, and acute effect. Heart Rhythm. 2019 Dec;16(12):1766-1773. doi: 10.1016/j.hrthm.2019.04.043. Epub 2019 Apr 29. |
| 32400967 | Background | Li X, Qiu C, Xie R, Ma W, Wang Z, Li H, Wang H, Hua W, Zhang S, Yao Y, Fan X. Left bundle branch area pacing delivery of cardiac resynchronization therapy and comparison with biventricular pacing. ESC Heart Fail. 2020 Aug;7(4):1711-1722. doi: 10.1002/ehf2.12731. Epub 2020 May 13. |
| 25446158 | Background | Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, Vijayaraman P. Permanent His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. Heart Rhythm. 2015 Feb;12(2):305-12. doi: 10.1016/j.hrthm.2014.10.021. Epub 2014 Oct 22. |
| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| 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 |
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