Comparing two pacemaker pacing methods for AV block
The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life
This trial tests whether conduction system (left bundle branch area) pacing or standard right ventricular pacing works better for people with atrioventricular block who need a permanent pacemaker.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Tartu Academic / other |
| Locations | 2 sites (Tallinn, Harju and 1 other locations) |
| Trial ID | NCT07276490 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-blind trial enrolling 124 adults with atrioventricular block who require permanent pacemaker implantation at two tertiary hospitals in Estonia. Participants are assigned to either conduction system pacing (left bundle branch area pacing) or standard right ventricular pacing and followed for 12 months. The primary outcome is central systolic arterial pressure, with secondary outcomes including measures of arterial stiffness, echocardiographic parameters, electrical activation patterns, and quality of life. The trial compares physiological central hemodynamics and cardiac function between the two pacing strategies.
Who should consider this trial
Good fit: Adults aged 18–80 with atrioventricular block who need a permanent pacemaker, have expected survival over one year, preserved left ventricular ejection fraction (≥45%), and are expected to have a ventricular pacing burden of ≥20% are ideal candidates.
Not a fit: Patients with reduced LVEF (<45%), expected ventricular pacing burden <20%, significant valvular or congenital heart disease, recent coronary revascularization, secondary hypertension, or pregnancy are unlikely to benefit from this specific comparison.
Why it matters
Potential benefit: If successful, the results could guide choice of pacing method to better preserve central blood pressure, heart function, and quality of life after pacemaker implantation.
How similar studies have performed: Previous nonrandomized studies and limited randomized data suggest conduction system pacing can better preserve electrical synchrony and cardiac function than right ventricular pacing, but larger randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tallinn, Harju and 1 other locations
- North Estonia Medical Centre — Tallinn, Harju, Estonia (Recruiting)
- Tartu University Hospital — Tartu, Tartu, Estonia (Recruiting)
Study contacts
- Study coordinator: Silver Heinsar, MD, PhD
- Email: silver.heinsar@ut.ee
- Phone: +372 5333 1997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.