The Boston Pace Study

Not Applicable

Recruiting

• Conditions: Left Bundle Branch Area Pacing
• Interventions: Device: Left Bundle Branch Area Pacemaker; Device: Right Ventricular Pacemaker

• Registration Number: NCT05869500
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed 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 Timeline

• Study First Submitted: 2023-04-17
• Status Verified: 2023-05
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Primary Completion: 2024-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. History of systolic dysfunction with LV EF of less than 50%
2. Prior myocardial infarction
3. Obstructive coronary artery disease
4. Severe valvular dysfunction
5. Life expectancy of less than a year
6. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Bundle Branch Area Pacing	Left Bundle Branch Area Pacemaker	-
Right Ventricular Pacing	Right Ventricular Pacemaker	-

Primary Outcome Measures

Name	Time	Method
Change in left ventricular ejection fraction (LVEF)	12 months
Change in left ventricular end systolic volume (LVESV)	12 months

Secondary Outcome Measures

Name	Time	Method
Pacing percentage	12 months
New York Heart Association Class I-IV (IV is worst)	12 months
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
Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram	12 months
Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram	12 months
Number of participants with new onset atrial fibrillation	12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)	12 months
Paced QRS duration on 12 lead EKG	Evaluated at 1 day, 30 days and 12 months
Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision	12 months
Procedure time	1 day
Fluoroscopy time	1 day
Pacing capture threshold (V)	12 months
R wave amplitude (mV)	12 months
RV lead impedance (ohms)	12 months

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States