Atrioventricular BlockPACE-CCQNCT07276490
Central Haemodynamics and Pacing for AV Block
A study testing Right ventricular pacing and Conduction system pacing in people with Atrioventricular Block and Pacing Therapy, run by University of Tartu at 2 sites in Estonia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrioventricular Block, Pacing Therapy, Right Ventricular Pacing
- What is being tested?
- Right ventricular pacing and Conduction system pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesEstonia
- Study dates
- 28 Nov 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Diagnosis of atrioventricular block
- Expected survival >1 year
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia2 sites, 2 recruiting
- Recruiting
North Estonia Medical Centre
Tallinn, Harju, 13419
Silver Heinsar, MD, PhD, +372 5333 1997, silver.heinsar@ut.ee
Priit Kampus, MD, PhD
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Priit Pauklin, MD, PhD, 5284692 ext. +372, Priit.Pauklin@kliinikum.ee
Priit Pauklin, MD, PhD
About this study
Official title: 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.
- Conditions
- Atrioventricular Block, Pacing Therapy, Right Ventricular Pacing, Conduction System Pacing
- Being tested
- Right ventricular pacing, Conduction system pacing
- Keywords
- conduction system pacing, atrioventricular block, right ventricular pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ventricular pacingDevice
Pacemaker implantation with RV lead placement
Conduction system pacingDevice
Pacemaker implantation with conduction system (LBBAP) lead placement
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular pacing | Active comparator | Not described Receives: Device: Right ventricular pacing |
| Conduction system pacing | Experimental | Not described Receives: Device: Conduction system pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central systolic blood pressure
Measured: One year post implantation of pacemaker
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start28 Nov 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Medical Centre, Tartu University Hospital
- Responsible party
- Principal investigator, Silver Heinsar, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276490
- Sponsor's protocol ID
- 405/M-27
- Acronym
- PACE-CCQ
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life
- ClinicalTrials.gov ID
- NCT07276490
- Acronym / sponsor ID
- PACE-CCQ / 405/M-27
- Conditions
- Atrioventricular Block, Pacing Therapy, Right Ventricular Pacing, Conduction System Pacing
- Keywords
- conduction system pacing, atrioventricular block, right ventricular pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- North Estonia Medical Centre, Tartu University Hospital
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular pacing | Active comparator | Device: Right ventricular pacing |
| Conduction system pacing | Experimental | Device: Conduction system pacing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Diagnosis of atrioventricular block
- Expected survival >1 year
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right ventricular pacingPacemaker implantation with RV lead placement | Device | Right ventricular pacing |
| Conduction system pacingPacemaker implantation with conduction system (LBBAP) lead placement | Device | Conduction system pacing |
Primary outcome
Central systolic blood pressure
Time frame: One year post implantation of pacemaker
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right ventricular pacing and Conduction system pacing in people with Atrioventricular Block and Pacing Therapy, run by University of Tartu at 2 sites in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silver Heinsar, MD, PhD (+372 5333 1997, silver.heinsar@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central systolic blood pressure (time frame: One year post implantation of pacemaker). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.