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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Implantation of Medtronic 3830 lead for left bundle branch area pacing
Implantation of a conventional right ventricular pacemaker lead
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGChange in left ventricular ejection fraction (LVEF)
Time frame: 12 months
Change in left ventricular end systolic volume (LVESV)
Time frame: 12 months
Success rate of LBBAP
Time frame: 30 days
All-cause mortality
Time frame: 12 months
Cardiovascular mortality
Time frame: 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
Time frame: 12 months
Number of participants with upgrade to cardiac resynchronization therapy
Time frame: 12 months
New York Heart Association Class I-IV (IV is worst)
Time frame: 12 months
Number of participants with occurrence of moderate or severe tricuspid regurgitation on echocardiogram
Time frame: 12 months
Number of participants with occurrence of moderate or severe mitral regurgitation on echocardiogram
Time frame: 12 months
Number of participants with new onset atrial fibrillation
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (score of 8-40)
Time frame: 12 months
Paced QRS duration on 12 lead EKG
Time frame: Evaluated at 1 day, 30 days and 12 months
Pacing percentage
Time frame: 12 months
Complication rate including pneumothorax, cardiac tamponade, infection, and lead revision
Time frame: 12 months
Procedure time
Time frame: 1 day
Fluoroscopy time
Time frame: 1 day
Pacing capture threshold (V)
Time frame: 12 months
R wave amplitude (mV)
Time frame: 12 months
RV lead impedance (ohms)
Time frame: 12 months
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