Central Haemodynamics and Pacing for AV Block (PACE-CCQ)

March 6, 2026 updated by: Silver Heinsar, University of Tartu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 13419
        • Recruiting
        • North Estonia Medical Centre
        • Contact:
        • Sub-Investigator:
          • Priit Kampus, MD, PhD
        • Sub-Investigator:
          • Jüri Voitk, MD
        • Sub-Investigator:
          • Martin Serg, MD, PhD
        • Sub-Investigator:
          • Madli Haldre, MD
        • Sub-Investigator:
          • Riina Voitk, RN
        • Sub-Investigator:
          • Inga Krutii, RN
        • Sub-Investigator:
          • Evelin Takkel, RN
        • Principal Investigator:
          • Silver Heinsar, MD, PhD
    • Tartu
      • Tartu, Tartu, Estonia, 50406
        • Recruiting
        • Tartu University Hospital
        • Contact:
        • Principal Investigator:
          • Priit Pauklin, MD, PhD
        • Sub-Investigator:
          • Indrek Roose, MD
        • Sub-Investigator:
          • Ulvi Eit, RN
        • Sub-Investigator:
          • Kaire Karindi, RN
        • Sub-Investigator:
          • Anette C Kõre, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Right ventricular pacing
Device: Right ventricular pacing
Pacemaker implantation with RV lead placement
Experimental: Conduction system pacing
Device: Conduction system pacing
Pacemaker implantation with conduction system (LBBAP) lead placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central systolic blood pressure
Time Frame: One year post implantation of pacemaker
One year post implantation of pacemaker

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Collaborators

Tartu University Hospital
North Estonia Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 405/M-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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