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NCT Number: NCT07276490

Central Haemodynamics and Pacing for AV Block

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.

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Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Conduction System Pacing Heart Block Heart Diseases Pacing Therapy Pathologic Processes Pathological Conditions, Signs and Symptoms Right Ventricular Pacing

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Estonia Medical Centre, Tallinn, Harju, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Right Ventricular Pacing

Device

Pacemaker implantation with RV lead placement

conduction system pacing

Device

Pacemaker implantation with conduction system (LBBAP) lead placement

Primary outcomes

  1. Central systolic blood pressure

    Time frame: One year post implantation of pacemaker

Study contacts

Contact information is provided by the study sponsor or research team.

Silver Heinsar, MD, PhD

CONTACT

[email protected]

+372 5333 1997

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • North Estonia Medical Centre
  • Tartu University Hospital

Registry information

Official study title

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

Acronym: PACE-CCQ

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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