Clinical trial NCT06782152: AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)
Official title: AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines
Keywords: Bradycardia
Sick Sinus Syndrome
Pacemaker
AV Block
Vasovagal Syncope
Heart Diseases
Cardiovascular Diseases
Pathologic Proceses
Arrhytmias, Cardiac
Lead sponsor: King Fahad Armed Forces Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-17
Enrollment: 1698
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject clinically indicated to receive a Leadless Pacemaker in adherence with ESC cardiac pacing guidelines.

Brief summary: The AVEIR™ 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 AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices.

Detailed description: The AVEIR™ 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 AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices. The study aims to evaluate safety profile, electrical performances and clinical outcomes in patients indicated for cardiac pacing after they receive Aveir LP systems. The Aveir VR LP system, for ventricular pacing, and the Aveir AR LP system for atrial pacing, and their concomitant use in the dual chamber configuration (Aveir DR LP system), have received the CE mark. The study also aims to understand clinical characteristics of patients receiving AVEIR™ leadless pacemaker devices in real-world clinical practice. The study Investigators will gather data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures are commercially available and already in use in the participating sites. The structure of this document provides a general overview and methodology of the study and a few specific details such as sample size, follow-up procedures, reporting requirements, and definitions.

Eligibility criteria: Inclusion Criteria:

1. Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
3. Subject agrees to return to clinic for the study follow-up visits.
4. 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:

1. Subject is currently participating in another study that may confound the results of this research.
2. Subject has a life expectancy less than 12 months.
3. Subject is pregnant or nursing or planning pregnancy during the study.
4. 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

   - Page 3 of 4 \[DRAFT\] - valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.
5. Subject is allergic/hypersensitive to \<1 mg dexamethasone sodium phosphate.
6. Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
7. Subject has known pacemaker syndrome, if that condition, in the investigator's opinion, represents a contraindication to the implant of the planned pacemaker.
8. Subject has pacing induced cardiomyopathy.

Primary outcomes:
measure: The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems
timeFrame: 12 momths
measure: Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months.
timeFrame: 12 months
measure: Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from device- or procedure-related major complications at 24 months
timeFrame: 24 months
measure: All adverse events, regardless device- or procedure-relatedness.
timeFrame: 48 months
measure: Implant success rate and reasons for unsuccessful implant.
timeFrame: 24 months
measure: Number of device repositioning at time of implantation.
timeFrame: 24 months
measure: Implant duration, fluoroscopy duration, and time from implant to hospital discharge.
timeFrame: 24 months
measure: Final LP placement site.
timeFrame: 24 months
measure: Demographics and medical history, with specific focus on indication for pacemaker implant and reasons for the choice of leadless pacemakers.
timeFrame: 24 months
measure: Device longevity, as displayed by the programmer at each visit.
timeFrame: 48 months
measure: Device programming and pacing and sensing conditions which may impact longevity.
timeFrame: 48 months
measure: Need for and success of device retrieval.
timeFrame: 48 months
measure: Number of hospitalizations and mortality.
timeFrame: 48 months
measure: Upgrade from Aveir VR to Aveir DR and from Aveir AR to Aveir DR.and Communication i2i success rate.
timeFrame: 48 months
measure: Development of pacing induced cardiomyopathy
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
References: