Heart Failure Clinical Trial
— LEAP-BlockOfficial title:
Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block): A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 458 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - a. Adult patients aged 18-90; - b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d)Symptomatic first degree AV block and PR interval on ECG = 250ms; - c. The subject is able to receive a pectoral implant; - d. The subject is willing and able to comply with the protocol; - e. The subject is expected to remain available for follow-up visits at the study centers. - f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent Exclusion Criteria: - a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%); - b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons; - c. Patients with persistent atrial fibrillation; - d. Pacemaker replacement without new implanted ventricular electrodes; - e. Patients with implantable cardioverter-defibrillator (ICD) indications; - f. Surgery is required within 1 year due to severe structural heart disease; - g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anzhen hospital, Capital Medical University | Beijing | Beijing |
China | Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
China | The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | Teda International Cardiovascular Hospital | Tianjin | Tianjin |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Fu Wai Hospital, Beijing, China | Affiliated Hospital of Qinghai University, Beijing Anzhen Hospital, Beijing Friendship Hospital, Chinese Society of Cardiology, First Affiliated Hospital of Chongqing Medical University, Fuwai Central China Cardiovascular Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Shanxi Cardiovascular Hospital, Teda International Cardiovascular Hospital, Tianjin, China, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Baseline QRSd based primary outcome | All-cause death and/or hospitalization for heart failure comparison based on baseline QRSd (>120ms vs. =120ms) | Within 2 years after device implantation | |
Primary | 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 | |
Secondary | 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. | Within 2 years after device implantation | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The occurrence of LV dyssynchrony | The occurrence of LV dyssynchrony will be evaluated by echocardiography during 2-year follow-up. | 24 months | |
Secondary | 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 | |
Secondary | 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 |
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