CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy

Официальное название

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

Обзор

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).

Подробное описание

RVP is a standardized treatment strategy for severe bradyarrhythmia. However, RVP can result in electrical and mechanical dyssynchrony of the heart, which will adversely affect cardiac function. Until now, many studies have shown that RVP can promote the progression of heart failure, especially in patients with high ventricular pacing percentage. For these heart failure patients, upgrading to CRT is a feasible and effective therapy.

BiVP is a traditional method to achieve CRT, which can improve cardiac synchrony and provide great clinical outcomes for heart failure patients upgraded from RVP. CSP contains left bundle branch pacing (LBBP) and His bundle pacing (HBP), which is able to activate native His-Purkinje conduction system and solve the problems caused by RVP. Although HBP has high technical requirements, lower sense value and higher threshold, it is the pacing modality closest to physiological conditions so far. Since first reported by Huang et al. in 2017, LBBP has been carried out boomingly all over the world. LBBP has been reported to offer higher success rate with higher sense value and lower pacing thresholds compared with HBP, which can also achieve similar electrical and mechanical resynchronization as well as HBP.

However, no randomized controlled studies have been reported to compare the efficacy of CSP and BiVP in patients with heart failure and RVP requiring upgrading to CRT. CSP-UPGRADE is a non-inferiority study, and the purpose of which is to investigate whether the efficacy of CSP is not inferior to BiVP in such patients. Eligible patients will be 1:1 randomized to two groups. The primary outcome is change in LVEF between baseline and six months after device implantation assessed by echocardiography. According to BUDAPEST-CRT Upgrade trial, half of lower limit of the 95% confidence interval for difference in mean ΔLVEF between the CRTD and ICD group is about 3.8%, which is used as non-inferiority margin in the present study. Based on previous studies and cases, it is assumed that the mean ΔLVEF values in patients upgraded to CSP and BiVP are equal and the standard deviations are both 5%. With power as 80%, alpha as 0.025, rate of lost-of-follow-up as 10%, the final sample size was estimated as 66 by using PASS Version 21.0.3 (33 patients for each group). If the non-inferiority test reaches positive results, then we will further verify whether CSP is superior to BiVP in such patients.

Вмешательства

• Устройство Conduction system pacing
  Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.
• Устройство Biventricular pacing
  Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.

Первичные конечные точки

• ΔLVEF [Срок оценки: Baseline; 6-month follow-up]

Вторичные конечные точки (12)

• ΔLVEDD [Срок оценки: Baseline; 3-month follow-up; 6-month follow-up]
• ΔLVEDV [Срок оценки: Baseline; 3-month follow-up; 6-month follow-up]
• ΔLVESV [Срок оценки: Baseline; 3-month follow-up; 6-month follow-up]
• Paced QRS duration [Срок оценки: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]
• Echocardiographic response rate [Срок оценки: Baseline; 6-month follow-up]
• Changes in NT-proBNP [Срок оценки: Baseline; 3-month follow-up; 6-month follow-up]
• Changes in New York Heart Association Heart Function Classification [Срок оценки: Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up]
• Changes in 6-minute Walk Distance [Срок оценки: Baseline; 3-month, 6-month follow-up]
• Change in Quality Of Life Questionnaire score [Срок оценки: Baseline; 3-month follow-up; 6-month follow-up]
• Incidence of clinical adverse events [Срок оценки: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]
• Procedure-related costs [Срок оценки: 1 day before discharge]
• Estimated longevity of the device [Срок оценки: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]

Критерии участия

Критерии включения

• Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;
• NYHA class II-IV;
• NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation;
• Right ventricular pacing percentage >40%;
• Adult patients aged 18-80;
• With informed consent signed.

Критерии исключения

• History of acute myocardial infarction within 3 months before enrollment;
• Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;
• History of valvular heart disease intervention within 3 months before enrollment;
• After mechanical tricuspid valve replacement;
• Ventricular septal hypertrophy (≥15mm during diastole);
• Complex congenital heart disease;
• History of heart transplantation;
• Enrollment in any other study;
• Pregnant or with child-bearing plan;
• A life expectancy of less than 12 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Публикации

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• 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 PMID 37283271
• 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. PMID 19695453
• 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. PMID 25189602
• 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. PMID 29749933
• 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. PMID 29081396
• 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. PMID 33372293
• 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/eur PMID 37632437

Идентификаторы

NCT: NCT06241651 · 2023-SR-811

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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