Comparing two pacing methods for heart failure patients
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
This study is testing whether a new pacing method called conduction system pacing can help heart failure patients just as much as the standard biventricular pacing to improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06241651 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with symptomatic heart failure and a left ventricular ejection fraction (LVEF) of less than 50% after at least 3 months of right ventricular pacing.
Not a fit: Patients with a history of acute myocardial infarction, significant arrhythmias, or other serious cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pacing method for heart failure patients, potentially improving their quality of life and cardiac function.
How similar studies have performed: While CSP has been gaining traction globally, this study is novel as it specifically compares CSP and BiVP in the context of heart failure patients upgraded from RVP.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.