BradyarrhythmiasBELLANCT07879716
Belgo-Luxembourg Leadless PM Registry
A study testing CT scan heart and 24 hour ambulatory ECG monitoring in people with Bradyarrhythmias and AV Block Complete, run by Universitaire Ziekenhuizen KU Leuven at 9 sites in 2 countries.
Trial summary
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1
- What is being tested?
- CT scan heart and 24 hour ambulatory ECG monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Nov 2026to 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this investigation must meet all of the following criteria:
- Voluntary written informed consent has been obtained from the participant or their legally authorized representative prior to any screening procedures.
- Participant is at least 18 years of age, or of legal age of consent, at the time of signing the Informed Consent Form (ICF).
- Participant has a clinical indication for cardiac pacing in accordance with the 2021 ESC Guidelines on Cardiac Pacing1.
- Participant is willing and able to comply with all study requirements as specified in the study protocol.
Who cannot join
- Participants eligible for this Investigation must not meet any of the following criteria:
- Subject implanted with an Aveir device on a non-permanent basis (e.g., CIED infection)
- Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to implant procedure)
- Subject currently enrolled or planning to participate in a potentially confounding drug or device study during the study.
- Subject meets any exclusion criteria required by local law (age or other).
- Subject has life expectancy less than 12 months.
Show all 9Show fewer
- Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
- Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with the site standard follow-up visits, for example a mechanical tricuspid valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.
- Subject is allergic/hypersensitive to <1 mg dexamethasone sodium phosphate.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
Belgium8 sites
ZAS Middelheim
Antwerp, 2020
Bruno Schwagten, M.D., +32 3 280 33 05, Bruno.schwagten@zas.be
UZ Brussel
Brussels, 1000
Ingrid Overeinder, PhD, +32 2 476 32 60, Ingrid.overeinder@uzbrussel.be
Erasme ziekenhuis
Brussels, 1070
Aurélien Wauters, PhD, 32 2 555 55 55, Aurelien.wauters@hubruxelles.be
AZ Maria Middelares
Ghent, 9000
Martijn Rogiers, MD, +32 (0)9 246 86 00, Martijn.rogiers@mijnziekenhuis.be
University Hospitals of Leuven
Leuven, Flemish Brabant, 3000
Christophe Garewg, PhD, +3216342079, christophe.garweg@uzleuven.be
CHR Citadelle
Liège, 4000
Jean-Manuel Herzet, MD, +32 4 321 70 31, jean.manuel.herzet@citadelle.be
Domaine universitaire du Sart Tilman
Liège, 4000
Patricio Lancelloti, PhD, +32 4 323 71 94, plancellotti@chuliege.be
AZ Delta
Roeselare, 8800
Bert Zwaenepoel, MD, +32 51 23 72 25, Bert.zwaenepoel@azdelta.be
Luxembourg1 site
CHL Luxembourg
Luxembourg, 1210
Laurent Groben, MD, +352 44 11 22 21, Groben.laurent@chl.lu
About this study
Official title: Belgo-Luxembourg Collaborative Research Network on AVEIR Leadless Pacemakers
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
The study is largely based on a standard-of-care protocol, with the exception of an additional 24-hour Holter monitoring assessment in a selected group of patients after one year, as well as a CT scan (at UZ Leuven only) to accurately determine the position of the pacemaker. The aim of this study is to evaluate real-world safety, electrical performance, and clinical outcomes in patients for whom cardiac pacing is indicated and who will receive or have received one of the Aveir™ LP systems:
- Aveir™ VR LP system, intended exclusively for ventricular pacing
- Aveir™ AR LP system, intended exclusively for atrial pacing
- Simultaneous use of the Aveir™ AR LP and VR LP systems for dual-chamber pacing
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker, Pacemaker Complication, Sick Sinus Node Syndrome
- Being tested
- CT scan heart, 24 hour ambulatory ECG monitoring
- Keywords
- bradycardia, leadless pacemaker, efficacy, safety
- Medical subject headings
- Bradycardia, Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scan heartRadiation
Acquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker
24 hour ambulatory ECG monitoringDiagnostic test
24 hour ambulatory ECG monitoring
| Study group | Role | What they receive |
|---|---|---|
| single arm population | Experimental | There is only one group of patients. No comparison between different groups. Receives: Radiation: CT scan heart; Diagnostic Test: 24 hour ambulatory ECG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety
The primary safety endpoint is 1/6-month, 1-year and 2-year incidence rate of leadless device-related or procedure-related major complications. In this context, the implant procedure will also be summarized.
Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision.
Measured: 1/6-month, 1-year and 2-year
Assesment of Electrical Efficacy: capture threshold
Ventricular pacing threshold is considered acceptable if <2.0 V at 0.4 ms
Atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms
Measured: 12 and 24 month FU
Assesment of Electrical Efficacy: R-wave and P-wave amplitude
R-wave amplitude is considered acceptable if >5.0 mV P-wave amplitude is considered adequate if ≥1.0 mV.
Measured: 12 and 24 month FU
Assesment of Efficacy: i2i communication betwoon both pacemakers
Acceptable i2i communication is defined as >80% in AVEIR DR systems as measured.
Measured: 12 and 24 month FU
AV synchrony and i2i communication in patients with high-degree AV block.
The i2i communication between both devices will be also specifically assessed in patients treated with Aveir DR for permanent high degree AV block (>80% VP). This will be validated by the acquisition of an ambulatory holter at the 12-month follow-up.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiasStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879716
- Sponsor's protocol ID
- S72011
- Other IDs
- Research grant
- Acronym
- BELLA
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The Declaration of Helsinki (most recent version) and European and Belgian regulations require that every research involving human participants be registered in a publicly accessible database before recruitment of the first participant. The CI is responsible for registering the Study. In addition, the CI will fulfil its ethical obligation to disseminate and make the research results publicly available. As such, the CI is accountable for the timeliness, completeness and accuracy of the reports. Researchers, authors, sponsors, editors and publishers must adhere to accepted guidelines for ethical reporting. Negative and inconclusive, as well as positive results, must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in publication. Publications will adhere to authorship criteria defined by the International Committee of Medical Journal Editors (ICMJE, uniform requirements for manuscripts submitted
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgo-Luxembourg Collaborative Research Network on AVEIR Leadless Pacemakers
- ClinicalTrials.gov ID
- NCT07879716
- Acronym / sponsor ID
- BELLA / S72011
- Conditions
- Bradyarrhythmias, AV Block Complete, AV Block-2Nd Degree-Type 1, Pacemaker, Pacemaker Complication, Sick Sinus Node Syndrome
- Keywords
- bradycardia, leadless pacemaker, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 19 Oct 2026 (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.
This is a single-arm, multicenter clinical study evaluating the long-term effectiveness and safety profile of the CE-marked and commercially available Aveir leadless pacemaker systems manufactured by Abbott.
The study is largely based on a standard-of-care protocol, with the exception of an additional 24-hour Holter monitoring assessment in a selected group of patients after one year, as well as a CT scan (at UZ Leuven only) to accurately determine the position of the pacemaker. The aim of this study is to evaluate real-world safety, electrical performance, and clinical outcomes in patients for whom cardiac pacing is indicated and who will receive or have received one of the Aveir™ LP systems:
- Aveir™ VR LP system, intended exclusively for ventricular pacing
- Aveir™ AR LP system, intended exclusively for atrial pacing
- Simultaneous use of the Aveir™ AR LP and VR LP systems for dual-chamber pacing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm population | Experimental | Radiation: CT scan heart, Diagnostic Test: 24 hour ambulatory ECG monitoringThere is only one group of patients. No comparison between different groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants eligible for inclusion in this investigation must meet all of the following criteria:
Key exclusion criteria (9 listed)
- Participants eligible for this Investigation must not meet any of the following criteria:
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 |
|---|---|---|
| CT scan heartAcquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker | Radiation | single arm population |
| 24 hour ambulatory ECG monitoring24 hour ambulatory ECG monitoring | Diagnostic test | single arm population |
Primary outcome
Assessment of safety
Time frame: 1/6-month, 1-year and 2-year
The primary safety endpoint is 1/6-month, 1-year and 2-year incidence rate of leadless device-related or procedure-related major complications. In this context, the implant procedure will also be summarized. Major complications are defined as events related to the leadless pacing system or leadless pacing system implant procedure resulting in death, permanent loss of device function due to mechanical or electrical dysfunction, hospitalization, prolonged hospitalization by at least 48 h, or system revision.
Assesment of Electrical Efficacy: capture threshold
Time frame: 12 and 24 month FU
Ventricular pacing threshold is considered acceptable if <2.0 V at 0.4 ms Atrial capture threshold is considered acceptable if ≤3.0 V at 0.4 ms
Assesment of Electrical Efficacy: R-wave and P-wave amplitude
Time frame: 12 and 24 month FU
R-wave amplitude is considered acceptable if >5.0 mV P-wave amplitude is considered adequate if ≥1.0 mV.
Assesment of Efficacy: i2i communication betwoon both pacemakers
Time frame: 12 and 24 month FU
Acceptable i2i communication is defined as >80% in AVEIR DR systems as measured.
AV synchrony and i2i communication in patients with high-degree AV block.
Time frame: 12-months
The i2i communication between both devices will be also specifically assessed in patients treated with Aveir DR for permanent high degree AV block (>80% VP). This will be validated by the acquisition of an ambulatory holter at the 12-month follow-up.
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. The Declaration of Helsinki (most recent version) and European and Belgian regulations require that every research involving human participants be registered in a publicly accessible database before recruitment of the first participant. The CI is responsible for registering the Study. In addition, the CI will fulfil its ethical obligation to disseminate and make the research results publicly available. As such, the CI is accountable for the timeliness, completeness and accuracy of the reports. Researchers, authors, sponsors, editors and publishers must adhere to accepted guidelines for ethical reporting. Negative and inconclusive, as well as positive results, must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in publication. Publications will adhere to authorship criteria defined by the International Committee of Medical Journal Editors (ICMJE, uniform requirements for manuscripts submitted
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan heart and 24 hour ambulatory ECG monitoring in people with Bradyarrhythmias and AV Block Complete, run by Universitaire Ziekenhuizen KU Leuven at 9 sites in 2 countries.
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 9 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, Luxembourg. 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 Christophe Garweg, PhD (+3216342079, christophe.garweg@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety (time frame: 1/6-month, 1-year and 2-year). The study lists 5 primary outcomes in all. 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 19 Oct 2026.