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NCT07534917

Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.

Sponsor: Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2026-07-01

Completion Date

2029-06-01

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

OTHER

Temporary left bundle branch area pacing

Temporary left bundle branch area pacing using a multielectrode catheter

OTHER

Temporary leadless right ventricular pacing

Temporary leadless right ventricular pacing using multielectrode catheter