The Boston Pace Study

NCT05869500 | Active Not Recruiting FDA Device

• 1 other identifier: 2022P003143
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Left Bundle Branch Area Pacing

Keywords

left bundle branch; left bundle

Outcome Measures

Primary Outcomes (2)

• Change in left ventricular ejection fraction (LVEF)

  12 months

• Change in left ventricular end systolic volume (LVESV)

  12 months

Secondary Outcomes (18)

• Success rate of LBBAP

  30 days

• All-cause mortality

  12 months

• Cardiovascular mortality

  12 months

• Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy

  12 months

• Number of participants with upgrade to cardiac resynchronization therapy

  12 months

Study Arms (2)

Left Bundle Branch Area Pacing

EXPERIMENTAL

Device: Left Bundle Branch Area Pacemaker

Right Ventricular Pacing

ACTIVE COMPARATOR

Device: Right Ventricular Pacemaker

Interventions

Left Bundle Branch Area Pacemaker DEVICE

Implantation of Medtronic 3830 lead for left bundle branch area pacing

Left Bundle Branch Area Pacing

Right Ventricular Pacemaker DEVICE

Implantation of a conventional right ventricular pacemaker lead

Right Ventricular Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Patients with complete AV block, high-grade AV block with an anticipated ventricular pacing rate of more than 40%
• Left ventricular ejection fraction of 50% or more.
• Echocardiogram within the last 3 months

You may not qualify if:

• History of systolic dysfunction with LV EF of less than 50%
• Prior myocardial infarction
• Obstructive coronary artery disease
• Severe valvular dysfunction
• Life expectancy of less than a year
• Pregnancy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Medtronic: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (2)