Heart Failure Clinical Trial
— CSP-UPGRADEOfficial title:
Conduction System Pacing Versus Biventricular Pacing for Heart Failure Patients With Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy: a Prospective Multicenter Non-inferiority Randomized Controlled Study
The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
Status | Recruiting |
Enrollment | 66 |
Est. completion date | March 1, 2026 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months; 2. NYHA class II-IV; 3. NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation; 4. Right ventricular pacing percentage >40%; 5. Adult patients aged 18-80; 6. With informed consent signed. Exclusion Criteria: 1. History of acute myocardial infarction within 3 months before enrollment; 2. Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control; 3. History of valvular heart disease intervention within 3 months before enrollment; 4. After mechanical tricuspid valve replacement; 5. Ventricular septal hypertrophy (=15mm during diastole); 6. Complex congenital heart disease; 7. History of heart transplantation; 8. Enrollment in any other study; 9. Pregnant or with child-bearing plan; 10. A life expectancy of less than 12 months. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | First Affiliated Hospital, Sun Yat-Sen University, Huizhou Third People's Hospital, Guangzhou Medical University, Meizhou People's Hospital, Nanfang Hospital, Southern Medical University, Rugao People's Hospital, Shantou Central Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Changzhou Second People's Hospital of Nanjing Medical University, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Zhangjiagang Hospital of Soochow University, The First Affiliated Hospital of Soochow University, The Third Affiliated Hospital of Soochow University, Third Affiliated Hospital, Sun Yat-Sen University |
China,
Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora V, Birgersdotter-Green UM, Cha YM, Chung EH, Cronin EM, Curtis AB, Cygankiewicz I, Dandamudi G, Dubin AM, Ensch DP, Glotzer TV, Gold MR, Goldberger ZD, Gopinathannair R, Gorodeski EZ, Gutierrez A, Guzman JC, Huang W, Imrey PB, Indik JH, Karim S, Karpawich PP, Khaykin Y, Kiehl EL, Kron J, Kutyifa V, Link MS, Marine JE, Mullens W, Park SJ, Parkash R, Patete MF, Pathak RK, Perona CA, Rickard J, Schoenfeld MH, Seow SC, Shen WK, Shoda M, Singh JP, Slotwiner DJ, Sridhar ARM, Srivatsa UN, Stecker EC, Tanawuttiwat T, Tang WHW, Tapias CA, Tracy CM, Upadhyay GA, Varma N, Vernooy K, Vijayaraman P, Worsnick SA, Zareba W, Zeitler EP. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm. 2023 Sep;20(9):e17-e91. doi: 10.1016/j.hrthm.2023.03.1538. Epub 2023 May 20. — View Citation
Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available. Erratum In: Eur Heart J. 2022 May 1;43(17):1651. — View Citation
Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4. — View Citation
Khurshid S, Obeng-Gyimah E, Supple GE, Schaller R, Lin D, Owens AT, Epstein AE, Dixit S, Marchlinski FE, Frankel DS. Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy. JACC Clin Electrophysiol. 2018 Feb;4(2):168-177. doi: 10.1016/j.jacep.2017.10.002. Epub 2017 Nov 15. — View Citation
Merkely B, Hatala R, Wranicz JK, Duray G, Foldesi C, Som Z, Nemeth M, Goscinska-Bis K, Geller L, Zima E, Osztheimer I, Molnar L, Karady J, Hindricks G, Goldenberg I, Klein H, Szigeti M, Solomon SD, Kutyifa V, Kovacs A, Kosztin A. Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial. Eur Heart J. 2023 Oct 21;44(40):4259-4269. doi: 10.1093/eurheartj/ehad591. — View Citation
Qian Z, Wang Y, Hou X, Qiu Y, Wu H, Zhou W, Zou J. Efficacy of upgrading to left bundle branch pacing in patients with heart failure after right ventricular pacing. Pacing Clin Electrophysiol. 2021 Mar;44(3):472-480. doi: 10.1111/pace.14147. Epub 2021 Jan 31. — View Citation
Shan P, Su L, Zhou X, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA, Huang W. Beneficial effects of upgrading to His bundle pacing in chronically paced patients with left ventricular ejection fraction <50. Heart Rhythm. 2018 Mar;15(3):405-412. doi: 10.1016/j.hrthm.2017.10.031. Epub 2017 Nov 16. — View Citation
Tops LF, Schalij MJ, Bax JJ. The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy. J Am Coll Cardiol. 2009 Aug 25;54(9):764-76. doi: 10.1016/j.jacc.2009.06.006. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ?LVEF | Change in LVEF between baseline and six months after device implantation | Baseline; 6-month follow-up | |
Secondary | ?LVEDD | Change in LVEDD between baseline and follow-up | Baseline; 3-month follow-up; 6-month follow-up | |
Secondary | ?LVEDV | Change in LVEDV between baseline and follow-up | Baseline; 3-month follow-up; 6-month follow-up | |
Secondary | ?LVESV | Change in LVESV between baseline and follow-up | Baseline; 3-month follow-up; 6-month follow-up | |
Secondary | Paced QRS duration | Paced QRS duration is evaluated before discharge and follow-up | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | |
Secondary | Echocardiographic response rate | The percentage of patients responding to CRT upgrade assessed by echocardiography | Baseline; 6-month follow-up | |
Secondary | Changes in NT-proBNP | The changes of NT-proBNP between baseline and follow-up | Baseline; 3-month follow-up; 6-month follow-up | |
Secondary | Changes in New York Heart Association Heart Function Classification | The higher the classification, the more severe the heart failure symptoms (four levels: I, II, III and IV) | Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up | |
Secondary | Changes in 6-minute Walk Distance | Distance that a participant walk within 6 minutes | Baseline; 3-month, 6-month follow-up | |
Secondary | Change in Quality Of Life Questionnaire score | Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome | Baseline; 3-month follow-up; 6-month follow-up | |
Secondary | Incidence of clinical adverse events | Including all-cause mortality, cardiovascular mortality, heart failure hospitalization and malignant ventricular arrhythmia | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | |
Secondary | Procedure-related costs | Costs related to device implantation | 1 day before discharge | |
Secondary | Estimated longevity of the device | The longevity of the device will be estimated during pacemaker test | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | |
Secondary | Pacing parameters | Number of atrial fibrillation and NSVT/VT | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | |
Secondary | Pacemaker related complications | Including but not limited to hemorrhage, pneumothorax, pericardial effusion, device-related infection and lead displacement | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up |
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