Comparing two pacing methods for heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of conduction system pacing (CSP) compared to biventricular pacing (BiVP) in heart failure patients who have been upgraded from right ventricular pacing (RVP) to cardiac resynchronization therapy (CRT). It is a multicenter, non-inferiority, randomized controlled trial designed to determine if CSP is as effective as BiVP in improving cardiac function. The study focuses on patients with symptomatic heart failure and aims to address the issues caused by RVP, which can lead to heart function deterioration. By comparing these two pacing methods, the study seeks to provide insights into the best treatment options for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jiangang Zou
• Email: jgzou@njmu.edu.cn
• Phone: 86-13605191407

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.