RecruitingNot ApplicableNCT07276490

Central Haemodynamics and Pacing for AV Block

The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life


Sponsor

University of Tartu

Enrollment

124 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Age 18-80 years
  • Diagnosis of atrioventricular block
  • Expected survival \>1 year

Exclusion Criteria12

  • 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
  • Secondary hypertension
  • Orthostatic hypotension
  • Clinically significant valvular heart disease
  • Congenital heart disease
  • Pulse wave analysis or pulse wave velocity measurement cannot be reliably performed
  • Pregnancy or breastfeeding
  • Withdrawal of consent by the subject
  • Loss of contact during the study

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Interventions

DEVICERight ventricular pacing

Pacemaker implantation with RV lead placement

DEVICEConduction system pacing

Pacemaker implantation with conduction system (LBBAP) lead placement


Locations(2)

North Estonia Medical Centre

Tallinn, Harju, Estonia

Tartu University Hospital

Tartu, Tartu, Estonia

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NCT07276490


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