CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
Recruiting · NCT06241651 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Biventricular pacingConduction system pacing
What this trial is about
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).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The First Affiliated Hospital with Nanjing Medical University - Nanjing, Jiangsu, China