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

NCT ID: NCT06782152

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1698 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2028-12-31

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.

Conditions

Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Fahad Armed Forces Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fayez Bokhari

Medical Director - Head of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Version A

Identifier Type: -

Identifier Source: org_study_id