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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: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-16

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 is associated with an increased risk of valve dysfunction and mortality as well as impairment of heart 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 the heart and tricuspid valve, as well as how they compare against each other, is unclear.

We aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and tricuspid valve by conducting an acute study that will be performed in addition to the routine pacemaker implantation that the participant has been referred for. Both procedures will be performed in one sitting under general anaesthesia. Outcomes from this study will improve our understanding of how these pacing technologies affect heart and valve function and how they compare against each other. This will guide decision-making regarding the ideal type of pacemaker to be adopted, especially in patients who stand to suffer the most from developing tricuspid valve or heart dysfunction.

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
2026-06-01
Primary Completion
2029-01-30
Completion
2029-06-01

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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