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

NCT07534917 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-08-21

No results posted yet for this study

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.

Conditions

  • Pacemaker-Induced Cardiomyopathy
  • Tricuspid Regurgitation
  • Right Ventricular Dysfunction

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

Sponsors & Collaborators

Principal Investigators

  • Aldo Rinaldi, MD · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-18
Primary Completion
2029-01-30
Completion
2029-06-01

Countries

  • United Kingdom

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534917 on ClinicalTrials.gov