Clinical trial NCT05869500: The Boston Pace Study
Official title: Left Bundle Area Pacing Vs. Right Ventricular Pacing in Patients With Normal Left Ventricular Function -The Boston Pace Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Bundle Branch Area Pacing
Keywords: left bundle branch
left bundle
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: 12 months
measure: Change in left ventricular end systolic volume (LVESV)
timeFrame: 12 months
Secondary outcomes:
measure: Success rate of LBBAP
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 12 months
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Rate of heart failure related visit: defined as heart failure hospitalization or emergency room visit or urgent visit requiring intravenous heart failure therapy
timeFrame: 12 months
measure: Number of participants with upgrade to cardiac resynchronization therapy
timeFrame: 12 months
measure: New York Heart Association Class I-IV (IV is worst)
timeFrame: 12 months
measure: Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram
timeFrame: 12 months
measure: Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram
timeFrame: 12 months
measure: Number of participants with new onset atrial fibrillation
timeFrame: 12 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)
timeFrame: 12 months
measure: Paced QRS duration on 12 lead EKG
timeFrame: Evaluated at 1 day, 30 days and 12 months
measure: Pacing percentage
timeFrame: 12 months
measure: Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision
timeFrame: 12 months
measure: Procedure time
timeFrame: 1 day
measure: Fluoroscopy time
timeFrame: 1 day
measure: Pacing capture threshold (V)
timeFrame: 12 months
measure: R wave amplitude (mV)
timeFrame: 12 months
measure: RV lead impedance (ohms)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References: