An interventional study of Conduction system pacing and Biventricular pacing in Conduction System Pacing, Biventricular Pacing and Cardiac Resynchronization Therapy, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 66 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this group, CSP lead is attempted to be placed, including LBBP and HBP.
Device: Conduction system pacing
In this group, traditional RA lead , RV lead and LV lead are attempted to be placed.
Device: Biventricular 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.
Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.
ΔLVEF
Change in LVEF between baseline and six months after device implantation
Time frame: Baseline; 6-month follow-up
ΔLVEDD
Change in LVEDD between baseline and follow-up
Time frame: Baseline; 3-month follow-up; 6-month follow-up
ΔLVEDV
Change in LVEDV between baseline and follow-up
Time frame: Baseline; 3-month follow-up; 6-month follow-up
ΔLVESV
Change in LVESV between baseline and follow-up
Time frame: Baseline; 3-month follow-up; 6-month follow-up
Paced QRS duration
Paced QRS duration is evaluated before discharge and follow-up
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Echocardiographic response rate
The percentage of patients responding to CRT upgrade assessed by echocardiography
Time frame: Baseline; 6-month follow-up
Changes in NT-proBNP
The changes of NT-proBNP between baseline and follow-up
Time frame: Baseline; 3-month follow-up; 6-month follow-up
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)
Time frame: Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up
Changes in 6-minute Walk Distance
Distance that a participant walk within 6 minutes
Time frame: Baseline; 3-month, 6-month follow-up
Change in Quality Of Life Questionnaire score
Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome
Time frame: Baseline; 3-month follow-up; 6-month follow-up
Incidence of clinical adverse events
Including all-cause mortality, cardiovascular mortality, heart failure hospitalization and malignant ventricular arrhythmia
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Procedure-related costs
Costs related to device implantation
Time frame: 1 day before discharge
Estimated longevity of the device
The longevity of the device will be estimated during pacemaker test
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacing parameters
Number of atrial fibrillation and NSVT/VT
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Pacemaker related complications
Including but not limited to hemorrhage, pneumothorax, pericardial effusion, device-related infection and lead displacement
Time frame: 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University