Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of patients with acute pacemaker-induced cardiomyopathy
Study Overview
Brief Summary
Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.
Newer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.
The investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.
Detailed Description
Transvalvular right ventricular pacing (TVP) is a guideline-directed first-line treatment for high-degree AV block and sick sinus syndrome. However, TVP is associated with an increased risk of pacing-induced cardiomyopathy (PIM), tricuspid regurgitation (TR), and right ventricular dysfunction (RVD). Leadless right ventricular pacing (LP) and left bundle branch area pacing (LBBAP) are emerging as attractive alternatives to conventional TVP. While preliminary studies have investigated the impact of LP and LBBAP on left ventricular function, there is limited information on how these modalities compare with each other and their effects on right ventricular and tricuspid valve function. The investigators aim to perform an acute mechanistic study involving a head-to-head comparison of LBBAP and LP to evaluate their acute effects on biventricular and tricuspid valve function.
EXPERIMENTAL DETAILS AND DESIGN
Study design: Twenty patients will be prospectively recruited and undergo an acute mechanistic study during the same session prior to undergoing their allocated permanent pacemaker implantation, which will be performed according to standard clinical practice.
Study population
Inclusion criteria: Patients aged ≥18 years referred for permanent pacemaker implantation at a single centre (Guy's and St Thomas' NHS Foundation Trust, UK) with high-degree AV block, including Mobitz II and complete heart block, or scheduled for AV node ablation, and with LVEF ≥50%.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.
Exclusion Criteria
- •LVEF <50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy <1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.
Arms & Interventions
Patients referred for permanent pacemaker implantation
All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.
Intervention: Temporary left bundle branch area pacing (Other)
Patients referred for permanent pacemaker implantation
All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.
Intervention: Temporary leadless right ventricular pacing (Other)
Outcomes
Primary Outcomes
Proportion of patients with acute pacemaker-induced cardiomyopathy
Time Frame: From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)
All patients will undergo intraprocedural transesophageal echocardiogram (TEE) and temporary left bundle branch area pacing (LBBAP) and leadless right ventricular pacing (LP). Measurements of left ventricular ejection fraction (LVEF) will be taken before and after each pacing configuration. A drop of \>\>10% in LVEF to an LVEF of \<50% will be considered as acute pacing induced cardiomyopathy (PIM).
Secondary Outcomes
- Proportion of patients with tricuspid regurgitation (TR) progression(From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours))
- Proportion of patients with right ventricular dsyfunction(From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours))