Left Bundle Branch Area Pacing
Conditions
Keywords
left bundle branch, left bundle
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.
Interventions
DEVICELeft Bundle Branch Area Pacemaker
Implantation of Medtronic 3830 lead for left bundle branch area pacing
DEVICERight Ventricular Pacemaker
Implantation of a conventional right ventricular pacemaker lead
Sponsors
Massachusetts General Hospital
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular ejection fraction (LVEF) | 12 months |
| Change in left ventricular end systolic volume (LVESV) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| New York Heart Association Class I-IV (IV is worst) | 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 |
| Pacing percentage | 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 |
Countries
United States
Outcome results
None listed