Actively Recruiting
The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life
Led by University of Tartu · Updated on 2026-03-09
124
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Tartu
Lead Sponsor
N
North Estonia Medical Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two pacing methods for patients with atrioventricular block who need a permanent pacemaker. This study evaluates conduction system pacing (left bundle branch area pacing) against standard right ventricular pacing to understand their effects on heart function, blood flow, and quality of life over a 12-month period. It involves 124 patients from two Estonian hospitals and aims to measure central systolic arterial pressure as the main outcome. Participants will receive either a pacemaker implanted with a right ventricular lead or a conduction system lead placed in the left bundle branch area. This single-blind, randomized study will monitor patients over one year to assess differences between these two device-based pacing strategies. The main focus is on central blood pressure one year after implantation, with additional evaluations of arterial stiffness, heart ultrasound results, electrical heart activity patterns, and quality of life. Throughout the study, patients will undergo clinical assessments including blood pressure measurements, echocardiography, and pulse wave analysis to monitor heart and vascular function. Researchers will also evaluate quality of life scores. The study carefully tracks safety and device function during the one-year follow-up. The total participation period aligns with the 12-month post-implantation monitoring phase.
CONDITIONS
Brief Title
Central Haemodynamics and Pacing for AV Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years
- Diagnosis of atrioventricular block
- Expected survival greater than 1 year
You will not qualify if you...
- Reduced left ventricular ejection fraction (EF less than 45%)
- Expected ventricular pacing burden less than 20%
- Inter-arm systolic blood pressure difference greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo pacemaker implantation with either right ventricular pacing or conduction system pacing lead placement.
1 implantation visit (in-person)
Duration - Up to 1 year post implantation
Participants are monitored for heart function and central haemodynamics following the pacemaker implantation.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 2 locations
1
North Estonia Medical Centre
Tallinn, Harju, Estonia, 13419
Actively Recruiting
2
Tartu University Hospital
Tartu, Tartu, Estonia, 50406
Actively Recruiting
Research Team
S
Silver Heinsar, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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