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Compares treatment options for Conduction System Pacing
Official title CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
ClinicalTrials.gov ID: NCT06241651
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients with symptomatic heart failure (LVEF \<50%) after right ventricular pacing for at least 3 months;
- NYHA class II-IV;
- NT-proBNP \>125pg/mL in patients with sinus rhythm, NT-proBNP \>250pg/mL in patients with atrial fibrillation;
- Right ventricular pacing percentage \>40%;
- Adult patients aged 18-80;
You likely can't join if
- History of acute myocardial infarction within 3 months before enrollment;
- Frequent premature ventricular contraction (\>15%) or malignant ventricular arrhythmia which is difficult to control;
- History of valvular heart disease intervention within 3 months before enrollment;
- After mechanical tricuspid valve replacement;
- Ventricular septal hypertrophy (≥15mm during diastole);
- Complex congenital heart disease;
See the full eligibility criteria
- Patients with symptomatic heart failure (LVEF \<50%) after right ventricular pacing for at least 3 months;
- NYHA class II-IV;
- NT-proBNP \>125pg/mL in patients with sinus rhythm, NT-proBNP \>250pg/mL in patients with atrial fibrillation;
- Right ventricular pacing percentage \>40%;
- Adult patients aged 18-80;
- With informed consent signed.
- History of acute myocardial infarction within 3 months before enrollment;
- Frequent premature ventricular contraction (\>15%) or malignant ventricular arrhythmia which is difficult to control;
- History of valvular heart disease intervention within 3 months before enrollment;
- After mechanical tricuspid valve replacement;
- Ventricular septal hypertrophy (≥15mm during diastole);
- Complex congenital heart disease;
- History of heart transplantation;
- Enrollment in any other study;
- Pregnant or with child-bearing plan;
- A life expectancy of less than 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.