The Boston Pace Study

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05869500
• Collaborator: Medtronic (Industry)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 50
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Bundle Branch Area Pacing	Device: Left Bundle Branch Area Pacemaker; Device: Right Ventricular Pacemaker	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study
• Actual Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2024
• Anticipated Study Completion Date: Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left Bundle Branch Area Pacing	Device: Left Bundle Branch Area Pacemaker; Implantation of Medtronic 3830 lead for left bundle branch area pacing
Active Comparator: Right Ventricular Pacing	Device: Right Ventricular Pacemaker; Implantation of a conventional right ventricular pacemaker lead

Outcome Measures

Primary Outcome Measures

1. Change in left ventricular ejection fraction (LVEF) [12 months]

2. Change in left ventricular end systolic volume (LVESV) [12 months]

Secondary Outcome Measures

1. Success rate of LBBAP [30 days]

2. All-cause mortality [12 months]

3. Cardiovascular mortality [12 months]

4. 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]

5. Number of participants with upgrade to cardiac resynchronization therapy [12 months]

6. New York Heart Association Class I-IV (IV is worst) [12 months]

7. Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram [12 months]

8. Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram [12 months]

9. Number of participants with new onset atrial fibrillation [12 months]

10. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40) [12 months]

11. Paced QRS duration on 12 lead EKG [Evaluated at 1 day, 30 days and 12 months]

12. Pacing percentage [12 months]

13. Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision [12 months]

14. Procedure time [1 day]

15. Fluoroscopy time [1 day]

16. Pacing capture threshold (V) [12 months]

17. R wave amplitude (mV) [12 months]

18. RV lead impedance (ohms) [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Massachusetts General Hospital
• Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chee Yuan Ng, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05869500
• Other Study ID Numbers: 2022P003143
• First Posted: May 22, 2023
• Last Update Posted: May 22, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Chee Yuan Ng, MD, Principal Investigator, Massachusetts General Hospital: left bundle branch; left bundle

Study Results

No Results Posted as of May 22, 2023