Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Chee Yuan Ng
cyng1@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Chee Yuan Ng, MD
617-724-4500
cyng1@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.