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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Jan 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of helping patients with heart failure who have been receiving a specific type of pacing called right ventricular pacing (RVP). The researchers want to find out if a newer method called conduction system pacing (CSP) works just as well as the traditional biventricular pacing (BiVP) when upgrading patients to a therapy known as cardiac resynchronization therapy (CRT). The goal is to see if CSP can provide similar benefits for heart function in patients who have had RVP for at least three months and have certain heart failure symptoms.

To be eligible to participate, patients need to be between 18 and 80 years old and have heart failure with a reduced heart function (less than 50%). They should also have specific levels of a heart failure-related blood marker and have been experiencing symptoms categorized as NYHA class II to IV, which indicates varying levels of heart failure severity. Participants will be randomly assigned to receive either CSP or BiVP and will be closely monitored throughout the study. It’s important to note that individuals with recent heart attacks, certain heart conditions, or who are pregnant cannot join the trial. If you or a loved one are considering participation, this study could help advance treatment options for heart failure patients.

Gender

ALL

Eligibility criteria

• 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.