Central Haemodynamics and Pacing for AV Block

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Tartu

About this trial

A randomized, single-blind study comparing two pacing strategies in patients with atrioventricular block requiring permanent pacemaker implantation. This trial evaluates the impact of conduction system pacing (left bundle branch area pacing) versus standard right ventricular pacing on central hemodynamics, cardiac function, and patient quality of life over 12 months. The study will enroll 124 patients from two Estonian tertiary hospitals and measure central systolic arterial pressure as the primary outcome, with secondary assessments of arterial stiffness, echocardiographic parameters, electrical activation patterns, and quality of life scores.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years

Diagnosis of atrioventricular block

Expected survival >1 year

Disqualifiers

Reduced left ventricular ejection fraction (EF <45%)

Expected ventricular pacing burden <20%

Inter-arm systolic blood pressure difference >15 mmHg

Percutaneous coronary intervention or coronary artery bypass surgery within the last 30 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Right ventricular pacing

    Device

    Pacemaker implantation with RV lead placement

  • Conduction system pacing

    Device

    Pacemaker implantation with conduction system (LBBAP) lead placement

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Right ventricular pacingActive comparator 1 intervention
Group B: Conduction system pacingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Central systolic blood pressure

Time frame
One year post implantation of pacemaker

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Tartu

Lead sponsor

North Estonia Medical Centre

Collaborator

Tartu University Hospital

Collaborator