The Boston Pace Study

Status Recruiting

Clinical Trial Summary

Right ventricular (RV) pacing can cause left ventricular systolic dysfunction in 10- 20% of patients. Biventricular pacing had previously been shown to prevent left ventricular systolic dysfunction. However, implantation of coronary sinus lead increases procedural risk and can be limited by higher threshold and phrenic nerve capture. HIS pacing has been evaluated as an alternative pacing strategy, but its routine use was limited by difficulty of the procedure, success rate and high pacing threshold. Left bundle branch area pacing (LBBAP) is a promising physiologic pacing technique that has been proposed as a pacing strategy to prevent pacing induced cardiomyopathy and for treatment of desynchrony in heart failure. LBBAP has been adopted widely and performed routinely on patients with AV block. Currently, it is up to the discretion of the proceduralist whether LBBAP is performed given that there is lack of evidence to guide pacing strategies.

Clinical Trial Description

This pilot trial is a feasibility study that will assess for efficacy, safety and success rate of left bundle branch area pacing. The study will also examine the recruitment rate at 2 major tertiary hospitals. The study will examine if the use of LBBAP can prevent the occurrence of pacing induced cardiomyopathy (PICM) compared to RV pacing among patients with normal left ventricular function and high-grade AV block. The investigators hypothesize that the rate of pacing induced cardiomyopathy is lower with LBBAP compared to RV pacing in patients with normal left ventricular function requiring high burden of RV pacing. ;

Study Design

Related Conditions & MeSH terms

Left Bundle Branch Area Pacing

Clinical Trial Details

NCT number	NCT05869500
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Chee Yuan Ng, MD
Phone	617-724-4500
Email	cyng1@mgh.harvard.edu
Status	Recruiting
Phase	N/A
Start date	May 1, 2023
Completion date	April 30, 2025

View Details

See also
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Recruiting	`NCT03851315` - Left Bundle Branch Area Pacing in AVB Patients
Active, not recruiting	`NCT05102227` - Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.
Recruiting	`NCT05815745` - "Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)	N/A
Recruiting	`NCT05549544` - Clinical Efficacy of Left Bundle Branch Area Pacing for Patients With Permanent Atrial Fibrillation and Heart Failure	N/A
Not yet recruiting	`NCT06453850` - Safety and Performance Evaluation of a New Catheter Range for Lead Implantation at Interventricular Septum	N/A
Recruiting	`NCT05884411` - Evaluation of Left Bundle Branch Area Pacing As A Rescue Strategy for Cardiac Resynchronization Therapy Non-Response	N/A