The Boston Pace Study

Left Bundle Branch Area Pacing Clinical Trial

Official title:

Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869500
• Other study ID #: 2022P003143
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: Chee Yuan Ng, MD
• Phone: 617-724-4500
• Email: cyng1[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Bundle Branch Area Pacing

Intervention

Device:
• Left Bundle Branch Area Pacemaker
Implantation of Medtronic 3830 lead for left bundle branch area pacing
• Right Ventricular Pacemaker
Implantation of a conventional right ventricular pacemaker lead

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction (LVEF)		12 months
Primary	Change in left ventricular end systolic volume (LVESV)		12 months
Secondary	Success rate of LBBAP		30 days
Secondary	All-cause mortality		12 months
Secondary	Cardiovascular mortality		12 months
Secondary	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
Secondary	Number of participants with upgrade to cardiac resynchronization therapy		12 months
Secondary	New York Heart Association Class I-IV (IV is worst)		12 months
Secondary	Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram		12 months
Secondary	Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram		12 months
Secondary	Number of participants with new onset atrial fibrillation		12 months
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)		12 months
Secondary	Paced QRS duration on 12 lead EKG		Evaluated at 1 day, 30 days and 12 months
Secondary	Pacing percentage		12 months
Secondary	Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision		12 months
Secondary	Procedure time		1 day
Secondary	Fluoroscopy time		1 day
Secondary	Pacing capture threshold (V)		12 months
Secondary	R wave amplitude (mV)		12 months
Secondary	RV lead impedance (ohms)		12 months