RecruitingNCT06148571

Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal


Sponsor

Seoul National University Hospital

Enrollment

200 participants

Start Date

Oct 10, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still. Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety. This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer type of heart pacemaker called Left Bundle Branch Area Pacing (LBBAP) in people with heart failure whose heart pumps less blood than normal. The goal is to see if this pacing technique works better than standard options for improving heart function. **You may be eligible if...** - You have been diagnosed with heart failure and your heart's pumping strength (ejection fraction) is below 50% - Your doctor has recommended a pacemaker or cardiac resynchronization therapy - You are 19 years old or older **You may NOT be eligible if...** - You are under 19 years old - You are pregnant - Your life expectancy is less than 1 year - You have a mechanical tricuspid valve replacement - You only need pacing in the upper chambers of your heart (atrial pacing only) - You cannot receive a traditional (transvenous) pacemaker for any medical reason 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEleft bundle branch area pacing

left bundle branch area pacing locates ventricular lead into the interventricular septum to capture left bundle branch areas.


Locations(1)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06148571


Related Trials