Central Haemodynamics and Pacing for AV Block
PACE-CCQ
The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life
1 other identifier
interventional
124
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2025
CompletedStudy Start
First participant enrolled
November 28, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 9, 2026
November 1, 2025
1.5 years
November 28, 2025
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Central systolic blood pressure
One year post implantation of pacemaker
Study Arms (2)
Right ventricular pacing
ACTIVE COMPARATORConduction system pacing
EXPERIMENTALInterventions
Pacemaker implantation with conduction system (LBBAP) lead placement
Eligibility Criteria
You may qualify if:
- Age 18-80 years
- Diagnosis of atrioventricular block
- Expected survival \>1 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Tartulead
- North Estonia Medical Centrecollaborator
- Tartu University Hospitalcollaborator
Study Sites (2)
North Estonia Medical Centre
Tallinn, Harju, 13419, Estonia
Tartu University Hospital
Tartu, Tartu, 50406, Estonia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical researcher
Study Record Dates
First Submitted
November 28, 2025
First Posted
December 11, 2025
Study Start
November 28, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 9, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share