An interventional study of CT scan heart and 24 hour ambulatory ECG monitoring in Bradyarrhythmias, AV Block Complete and AV Block-2Nd Degree-Type 1, sponsored by Universitaire Ziekenhuizen KU Leuven. Not yet recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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:
313 studies on the registry are indexed under Bradycardia; 70 are open to participants now.
This study's planned enrollment of 190 is above the median of 99 across 179 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Participants eligible for inclusion in this investigation must meet all of the following criteria:
Exclusion Criteria:
Participants eligible for this Investigation must not meet any of the following criteria:
There is only one group of patients. No comparison between different groups.
Radiation: CT scan heart · Diagnostic Test: 24 hour ambulatory ECG monitoring
Acquisition of a CT scan heart to define the exact position of the atrial an ventricular leadless pacemaker
24 hour ambulatory ECG monitoring
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-months
Plan to share: 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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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