What is the mechanism of action of this treatment?

Left Bundle Branch Area Pacing (LBBAP) is a physiologic pacing technique designed to prevent pacing-induced cardiomyopathy and treat desynchrony in heart failure patients with Left Bundle Branch Block (LBBB). LBBAP works by directly stimulating the left bundle branch area, which helps to maintain synchronized contraction of the ventricles, thereby improving cardiac efficiency and function. This method contrasts with traditional right ventricular (RV) pacing, which can lead to left ventricular systolic dysfunction in a significant number of patients. By preserving the natural electrical conduction pathways, LBBAP reduces the risk of adverse effects associated with RV pacing, such as heart failure and reduced cardiac output, making it a promising treatment for patients with LBBB.

What side effects are associated with this type of intervention?

Left Bundle Branch Area Pacing (LBBAP) is a physiologic pacing technique used to prevent pacing-induced cardiomyopathy and treat desynchrony in heart failure. Common side effects and complications include procedural risks such as lead dislodgement, infection, and bleeding. Additionally, there may be challenges with high pacing thresholds and potential for phrenic nerve capture, which can cause diaphragmatic stimulation and discomfort. Despite these risks, LBBAP is generally considered a promising alternative to traditional pacing methods.

What prior FDA approvals exist?

The FDA has approved various pacing strategies for the treatment of Left Bundle Branch Block (LBBB), primarily focusing on biventricular pacing (also known as cardiac resynchronization therapy or CRT). CRT has been shown to improve symptoms and survival in patients with heart failure and LBBB by synchronizing the contractions of the left and right ventricles. While Left Bundle Branch Area Pacing (LBBAP) is a promising physiologic pacing technique aimed at preventing pacing-induced cardiomyopathy and treating desynchrony, it is still under study and has not yet received specific FDA approval. Current treatments for LBBB include CRT devices from manufacturers like Medtronic, Boston Scientific, and Abbott, which have been approved based on their ability to improve cardiac function and patient outcomes.

What other types of research exist?

Promising novel alternatives to Left Bundle Branch Area Pacing (LBBAP) for patients with Left Bundle Branch Block (LBBB) include: 1) Biventricular pacing, which has been shown to prevent left ventricular systolic dysfunction but comes with procedural risks such as higher thresholds and phrenic nerve capture. 2) HIS bundle pacing, which offers a physiologic pacing strategy but is limited by procedural difficulty and high pacing thresholds. These alternatives are being explored to improve outcomes in heart failure patients with LBBB.

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Pacemaker

LBBAP vs RV Pacemaker for Heart Pacing Issues

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new pacemaker placement method called LBBAP. It aims to help patients with normal heart function but severe AV block. The goal is to see if this method can prevent heart weakening compared to other methods. Left bundle branch area pacing (LBBaP) is a relatively new approach for physiologic pacing, showing promise in improving cardiac function.

Who is the study for?

The Boston Pace Study is for adults over 18 with complete or high-grade AV block expected to need a lot of ventricular pacing, and who have a left ventricular ejection fraction (LVEF) of 50% or more. They must have had an echocardiogram in the last three months. People with past heart muscle issues, recent heart attacks, blocked arteries, serious valve problems, short life expectancy or pregnancy cannot join.

What is being tested?

This study tests two types of pacemakers: Left Bundle Branch Area Pacemaker (LBBAP), which is newer and might prevent heart muscle problems caused by pacing; and Right Ventricular Pacemaker (RVP), the traditional option. The goal is to see if LBBAP can be a better standard for patients needing frequent ventricular pacing.

What are the potential side effects?

Pacemaker implantation may cause bleeding, infection at the site of surgery, lead displacement requiring repositioning, blood vessel damage during insertion, reaction to anesthesia used during procedure and rarely could cause puncture of the heart muscle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Left Bundle Branch Area PacingExperimental Treatment1 Intervention

Group II: Right Ventricular PacingActive Control1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Left Bundle Branch Area Pacing (LBBAP) is a physiologic pacing technique designed to prevent pacing-induced cardiomyopathy and treat desynchrony in heart failure patients with Left Bundle Branch Block (LBBB). LBBAP works by directly stimulating the left bundle branch area, which helps to maintain synchronized contraction of the ventricles, thereby improving cardiac efficiency and function. This method contrasts with traditional right ventricular (RV) pacing, which can lead to left ventricular systolic dysfunction in a significant number of patients. By preserving the natural electrical conduction pathways, LBBAP reduces the risk of adverse effects associated with RV pacing, such as heart failure and reduced cardiac output, making it a promising treatment for patients with LBBB.

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor

613 Previous Clinical Trials

759,633 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,621 Total Patients Enrolled

Media Library

Left Bundle Branch Area Pacemaker (Pacemaker) Clinical Trial Eligibility Overview. Trial Name: NCT05869500 — N/A

Left Bundle Branch Block Pacing Research Study Groups: Left Bundle Branch Area Pacing, Right Ventricular Pacing

Left Bundle Branch Block Pacing Clinical Trial 2023: Left Bundle Branch Area Pacemaker Highlights & Side Effects. Trial Name: NCT05869500 — N/A

Left Bundle Branch Area Pacemaker (Pacemaker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869500 — N/A

~43 spots leftby Sep 2025

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