Biventricular Pacing, Cardiac Resynchronization Therapy, Conduction System Pacing, Heart Failure, Right Ventricular Pacing
Conditions
Brief summary
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
DEVICEConduction 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.
DEVICEBiventricular pacing
Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Soochow University
The Affiliated Hospital of Xuzhou Medical University
The Third Affiliated Hospital of Soochow University
Rugao People's Hospital
Nanfang Hospital, Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Shantou Central Hospital
Meizhou People's Hospital
Changzhou Second People's Hospital affiliated with Nanjing Medical University
Zhangjiagang First People's Hospital
Huizhou Third People's Hospital, Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ΔLVEF | Baseline; 6-month follow-up | Change in LVEF between baseline and six months after device implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ΔLVEDD | Baseline; 3-month follow-up; 6-month follow-up | Change in LVEDD between baseline and follow-up |
| ΔLVEDV | Baseline; 3-month follow-up; 6-month follow-up | Change in LVEDV between baseline and follow-up |
| ΔLVESV | Baseline; 3-month follow-up; 6-month follow-up | Change in LVESV between baseline and follow-up |
| Paced QRS duration | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | Paced QRS duration is evaluated before discharge and follow-up |
| Echocardiographic response rate | Baseline; 6-month follow-up | The percentage of patients responding to CRT upgrade assessed by echocardiography |
| Changes in NT-proBNP | Baseline; 3-month follow-up; 6-month follow-up | The changes of NT-proBNP between baseline and follow-up |
| Changes in New York Heart Association Heart Function Classification | Baseline; 1-month follow-up; 3-month follow-up; 6-month follow-up | The higher the classification, the more severe the heart failure symptoms (four levels: I, II, III and IV) |
| Changes in 6-minute Walk Distance | Baseline; 3-month, 6-month follow-up | Distance that a participant walk within 6 minutes |
| Change in Quality Of Life Questionnaire score | Baseline; 3-month follow-up; 6-month follow-up | Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome |
| Incidence of clinical adverse events | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | Including all-cause mortality, cardiovascular mortality, heart failure hospitalization and malignant ventricular arrhythmia |
| Procedure-related costs | 1 day before discharge | Costs related to device implantation |
| Estimated longevity of the device | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | The longevity of the device will be estimated during pacemaker test |
| Pacing parameters | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | Number of atrial fibrillation and NSVT/VT |
| Pacemaker related complications | 1 day before discharge; 1-month follow-up; 3-month follow-up; 6-month follow-up | Including but not limited to hemorrhage, pneumothorax, pericardial effusion, device-related infection and lead displacement |
Countries
China
Contacts
CONTACTJiangang Zou
Outcome results
None listed