NCT06241651 CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
| NCT ID | NCT06241651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Conduction System Pacing |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2024-01-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06241651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Conduction System Pacing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06241651 currently recruiting?
Yes, NCT06241651 is actively recruiting participants. Contact the research team at jgzou@njmu.edu.cn for enrollment information.
Where is the NCT06241651 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06241651 clinical trial?
NCT06241651 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 66 participants.