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

RecruitingNAAges 18 Years - 80 YearsAllThe First Affiliated Hospital with Nanjing Medica…
NCT06241651 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Conduction system pacing
  • Biventricular pacing
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Where

1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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