AV BlockDANVERSNCT05856799
Danish Randomized Trial on Leadless vs Transvenous Pacing
A study testing Leadless Micra AV Transcatheter Pacing System and Transvenous Azure XT DR dual chamber pacemaker in people with AV Block, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- AV Block
- What is being tested?
- Leadless Micra AV Transcatheter Pacing System and Transvenous Azure XT DR dual chamber pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2023to Nov 2028
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing >80% of the time,
- Age 75 years or older
- Intact sinus node function
- Expected survival more than 12 months based on clinical evaluation
- Able to provide informed consent
Who cannot join
- Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT.
- Persistent, or chronic atrial fibrillation
- Reversible AVB
- Transient AVB due to ongoing ischemia
- Heart failure NYHA class III-IV
- Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class
Show all 14Show fewer
- Indication for primary or secondary prophylactic ICD implantation
- Acute myocardial infarction (AMI) within 3 months
- Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity
- Expected survival < 12 months based on clinical evaluation
- Performing high intensity sport
- Participation in another trial with experimental treatment
- Contraindication against device implantation (e.g., concurrent infection)
- Failure to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Cardiology Aarhus University Hospital
Aarhus, Region Midt, 8200
Department of Cardiology Odense University Hospital
Odense, Region Syd, 5000
About this study
Official title: Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.
- Conditions
- AV Block
- Being tested
- Leadless Micra AV Transcatheter Pacing System, Transvenous Azure XT DR dual chamber pacemaker
- Keywords
- Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease
- Medical subject headings
- Atrioventricular Block, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leadless Micra AV Transcatheter Pacing SystemDevice
Patients are implanted with a leadless Micra AV TPS
Transvenous Azure XT DR dual chamber pacemakerDevice
Patients are implanted with a transvenous Azure XT DR pacemaker
| Study group | Role | What they receive |
|---|---|---|
| Leadless Pacemaker | Active comparator | Implantation with a leadless pacemaker Receives: Device: Leadless Micra AV Transcatheter Pacing System |
| Transvenous pacemaker | Active comparator | Implantation with a transvenous pacemaker Receives: Device: Transvenous Azure XT DR dual chamber pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life by SF36
Self-reported health-related quality of life as measured by Short-Form 36 quality of life questionnaire. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life.
Measured: 7 months
Secondary outcomes (2)
Patient Acceptance by FPAS
Self-reported patient acceptance as measured by Florida Patient Acceptance Scale. The scale ranges from 0-100. 0 denotes minimal device acceptance and 100 denotes maximal device acceptance.
Measured: 7 months
Exercise capacity by 6MWT
Exercise capacity as measured by 6-minute walk test
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Sep 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV 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
- Model description
- Combined parallel and crossover randomized trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Mads B. Kronborg, DMSc, Principal investigator, Department of Cardiology Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856799
- Sponsor's protocol ID
- DANVERS2303101
- Acronym
- DANVERS
- Status last verified
- Apr 2026
- First submitted
- 3 May 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with Danish and European data protection law
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
- ClinicalTrials.gov ID
- NCT05856799
- Acronym / sponsor ID
- DANVERS / DANVERS2303101
- Conditions
- AV Block
- Keywords
- Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 12 May 2023 (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.
The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Combined parallel and crossover randomized trial
| Arm | Type | Receives |
|---|---|---|
| Leadless Pacemaker | Active comparator | Device: Leadless Micra AV Transcatheter Pacing SystemImplantation with a leadless pacemaker |
| Transvenous pacemaker | Active comparator | Device: Transvenous Azure XT DR dual chamber pacemakerImplantation with a transvenous pacemaker |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing >80% of the time,
- Age 75 years or older
- Intact sinus node function
- Expected survival more than 12 months based on clinical evaluation
- Able to provide informed consent
Key exclusion criteria (14 listed)
- Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT.
- Persistent, or chronic atrial fibrillation
- Reversible AVB
- Transient AVB due to ongoing ischemia
- Heart failure NYHA class III-IV
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 |
|---|---|---|
| Leadless Micra AV Transcatheter Pacing SystemPatients are implanted with a leadless Micra AV TPS | Device | Leadless Pacemaker |
| Transvenous Azure XT DR dual chamber pacemakerPatients are implanted with a transvenous Azure XT DR pacemaker | Device | Transvenous pacemaker |
Primary outcome
Quality of Life by SF36
Time frame: 7 months
Self-reported health-related quality of life as measured by Short-Form 36 quality of life questionnaire. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life.
2 secondary outcomes
Patient Acceptance by FPAS
Time frame: 7 months
Exercise capacity by 6MWT
Time frame: 7 months
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 29 Apr 2026.
- Individual participant dataSharing planned: No. In accordance with Danish and European data protection law
Related trials for AV Block
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
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Belgo-Luxembourg Leadless PM Registry
Bradyarrhythmias, AV Block Complete
Recruiting
Novel Approach to Conduction System Pacing With Use of Ultrasound
Conduction Block, Atrioventricular, Bundle-Branch Block
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AVEIR DR Coverage With Evidence Development (CED) Study
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Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
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. This study is not recruiting at the moment.
Mads B. Kronborg, DMSc principal investigator
Department of Cardiology Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leadless Micra AV Transcatheter Pacing System and Transvenous Azure XT DR dual chamber pacemaker in people with AV Block, run by University of Aarhus at 2 sites in Denmark.
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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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 Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life by SF36 (time frame: 7 months). 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 29 Apr 2026.