AVEIRâ„¢ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS) (NCT06782152) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AVEIRâ„¢ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
1,698 participantsStarted 2025-01-06
Plain-language summary
The AVEIRâ„¢ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIRâ„¢ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
✓. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
✓. Subject agrees to return to clinic for the study follow-up visits.
✓. Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by IRB/EC.
Exclusion criteria
✕. Subject is currently participating in another study that may confound the results of this research.
✕. Subject has a life expectancy less than 12 months.
✕. Subject is pregnant or nursing or planning pregnancy during the study.
✕. 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
✕. Subject is allergic/hypersensitive to \<1 mg dexamethasone sodium phosphate.
✕. 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 known pacemaker syndrome, if that condition, in the investigator's opinion, represents a contraindication to the implant of the planned pacemaker.
What they're measuring
1
The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems
Timeframe: 12 momths
2
Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months.
Timeframe: 12 months
3
Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months.