AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)

Launched by KING FAHAD ARMED FORCES HOSPITAL · Jan 13, 2025

Keywords

ClinConnect Summary

The PREMIER LEADLESS trial is studying the AVEIR™ leadless pacemaker, a small device that helps regulate heartbeats without the need for traditional wires. This research aims to understand how safe and effective these leadless pacemakers are when used in real-life situations, and to learn more about the patients who receive them. The study will take place in several centers across Europe and the Middle East, and will look at the experiences of patients who need cardiac pacing to keep their hearts beating normally.

To be eligible for this trial, participants must be at least 18 years old and have a medical need for a pacemaker according to specific heart health guidelines. They should also be willing to return for follow-up visits after the device is implanted. However, those currently involved in other studies, with a life expectancy of less than a year, or who have certain health conditions may not be able to participate. Participants can expect to be closely monitored throughout the study to ensure their safety and gather important data about how well the pacemaker works.

Gender

ALL

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.