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Recruiting NCT06241651

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

No phase Interventional Conduction System Pacing Biventricular Pacing Cardiac Resynchronization Therapy Right Ventricular Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conduction system pacing, Biventricular pacing.
Who it may be relevant to
Registry conditions: Conduction System Pacing, Biventricular Pacing, Cardiac Resynchronization Therapy, Right Ventricular Pacing. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Detailed description

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.

Interventions

  • Device 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.
  • Device Biventricular pacing
    Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.

Primary outcome measures

  • ΔLVEF [Time frame: Baseline; 6-month follow-up]
Secondary outcome measures (12)
  • ΔLVEDD [Time frame: Baseline; 3-month follow-up; 6-month follow-up]
  • ΔLVEDV [Time frame: Baseline; 3-month follow-up; 6-month follow-up]
  • ΔLVESV [Time frame: Baseline; 3-month follow-up; 6-month follow-up]
  • Paced QRS duration [Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]
  • Echocardiographic response rate [Time frame: Baseline; 6-month follow-up]
  • Changes in NT-proBNP [Time frame: Baseline; 3-month follow-up; 6-month follow-up]
  • Changes in New York Heart Association Heart Function Classification [Time frame: Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up]
  • Changes in 6-minute Walk Distance [Time frame: Baseline; 3-month, 6-month follow-up]
  • Change in Quality Of Life Questionnaire score [Time frame: Baseline; 3-month follow-up; 6-month follow-up]
  • Incidence of clinical adverse events [Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]
  • Procedure-related costs [Time frame: 1 day before discharge]
  • Estimated longevity of the device [Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Publications

  • 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. 202 PMID 34455430
  • 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

Identifiers

NCT: NCT06241651 · 2023-SR-811

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗