CSP Versus BiVP for Heart Failure Patients with RVP Upgraded to Cardiac Resynchronization Therapy
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 First Affiliated Hospital with Nanjing Medical University
66 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06241651