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Recruiting NCT07276490

Central Haemodynamics and Pacing for AV Block

No phase Interventional Atrioventricular Block Pacing Therapy Right Ventricular Pacing Conduction System Pacing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Right ventricular pacing, Conduction system pacing.
Who it may be relevant to
Registry conditions: Atrioventricular Block, Pacing Therapy, Right Ventricular Pacing, Conduction System Pacing. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Estonia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Right ventricular pacing
    Pacemaker implantation with RV lead placement
  • Device Conduction system pacing
    Pacemaker implantation with conduction system (LBBAP) lead placement

Primary outcome measures

  • Central systolic blood pressure [Time frame: One year post implantation of pacemaker]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Estonia · 2 centers
  • North Estonia Medical Centre — Tallinn
  • Tartu University Hospital — Tartu

Identifiers

NCT: NCT07276490 · 405/M-27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗