Tricuspid Regurgitation Clinical Trials

Find Tricuspid Regurgitation Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%.

Locations
Other Locations
United Kingdom
St. Thomas' Hospital
RECRUITING
London
Contact Information
Primary
Aldo Rinaldi, MD
aldo.rinaldi@kcl.ac.uk
+44207 188 9275
Backup
Alphonsus C Liew, MBBS
alphonsus.liew@kcl.ac.uk
+4420 7188 5442
Time Frame
Start Date: 2026-08-18
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 20
Treatments
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%.
Related Therapeutic Areas
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust
Collaborators: King's College London

This content was sourced from clinicaltrials.gov