Compare leadless and left bundle branch pacemakers for heart and valve function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will recruit twenty adults referred for permanent pacemaker implantation and perform an acute, mechanistic comparison of temporary leadless right ventricular pacing and temporary left bundle branch area pacing during the same session before the final device is implanted. Outcomes will focus on biventricular function and tricuspid valve performance to understand the short-term cardiac effects of these newer pacing approaches compared with conventional pacing considerations. Participants have high-degree AV block or are scheduled for AV node ablation and an ejection fraction of 50% or higher. The study is conducted at Guy's and St Thomas' NHS Foundation Trust, with collaboration from King's College London, and uses standard clinical procedures for implantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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%.

Exclusion Criteria:

* 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.

Where it's running

• St. Thomas' Hospital
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Aldo Rinaldi, MD — Guy's and St Thomas' NHS Foundation Trust
• Study coordinator: Aldo Rinaldi, MD
• Email: aldo.rinaldi@kcl.ac.uk
• Phone: +44207 188 9275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.