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

NCT07534917 | Not Yet Recruiting

• 1 other identifier: 348341
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

leadless pacemaker; left bundle branch area pacing; pacemaker-induced cardiomyopathy; tricuspid regurgitation; right ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with acute pacemaker-induced cardiomyopathy

  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).

  From the start of mechanistic study until the end of the mechanistic study (i.e. approximately 2 hours)

Secondary Outcomes (2)

• 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)

Study Arms (1)

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%.

Other: Temporary left bundle branch area pacing; Other: Temporary leadless right ventricular pacing

Interventions

Temporary left bundle branch area pacing OTHER

Temporary left bundle branch area pacing using a multielectrode catheter

Patients referred for permanent pacemaker implantation

Temporary leadless right ventricular pacing OTHER

Temporary leadless right ventricular pacing using multielectrode catheter

Patients referred for permanent pacemaker implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred for permanent pacemaker implantation with preserved LVEF at baseline.

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Study Officials

• Aldo Rinaldi, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Rinaldi, MD

CONTACT

+44207 188 9275; aldo.rinaldi@kcl.ac.uk

Alphonsus C Liew, MBBS

CONTACT

+4420 7188 5442; alphonsus.liew@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 30, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share