RecruitingNot ApplicableNCT06241651

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

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

66 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of cardiac resynchronization therapy (CRT) — a pacemaker upgrade that helps both sides of the heart beat in sync — in people with heart failure whose heart function has worsened from long-term right-sided pacing. The two approaches are conduction system pacing (CSP) and traditional biventricular pacing (BiVP). **You may be eligible if...** - You have symptomatic heart failure (reduced heart pumping function, LVEF below 50%) after having a right ventricular pacemaker for at least 3 months - You are in NYHA class II–IV (symptoms ranging from mild to severe) - Your pacemaker is pacing the right ventricle more than 40% of the time - Your NT-proBNP blood test is elevated (above 125 pg/mL in normal heart rhythm, or above 250 pg/mL if you have atrial fibrillation) - You are between 18 and 80 years old **You may NOT be eligible if...** - You have had a heart attack within the past 3 months - You have frequent or difficult-to-control abnormal heart rhythms - You have a mechanical tricuspid heart valve - You are pregnant or planning pregnancy - Your life expectancy is less than 12 months - You have complex congenital heart disease or a previous heart transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEConduction system pacing

Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.

DEVICEBiventricular pacing

Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06241651


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