What is this study trying to find out about pacemakers?

This study is observing how safe and effective the AVEIR VR LP and AVEIR AR LP leadless pacemaker devices are for patients needing pacemakers. It aims to understand how these devices perform in real-world use in France. The French Cardiology Society sponsors this registry to gather important patient and device information.

Who may be eligible for this pacemaker clinical trial?

Adults 18 years or older who have been or will be implanted with an AVEIR VR LP or AVEIR AR LP device may be eligible. The trial accepts all genders, but participants must agree to join after being informed. Patients under 18 or those refusing participation cannot join. Please review eligibility criteria for more details.

Is there any cost to participate in this pacemaker clinical trial?

Study-related care, including monitoring and follow-up visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants should plan for any travel costs themselves.

Actively Recruiting

Age: 18Years +

All Genders

ID06262295

France LEADLESS Registry Monitoring Safety and Effectiveness of AVEIR VR LP and AVEIR AR LP Pacemakers in Adults

Led by French Cardiology Society · Updated on 2026-03-09

1000

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the AVEIR VR LP and AVEIR AR LP leadless pacemaker systems in patients who need pacemakers in France. This national registry study, called France LEADLESS, aims to confirm how these devices perform under normal conditions in patients needing VVIR, AAIR, or DDDR pacemakers, and to collect information about patient characteristics and device indications. The study is observational, retrospective and prospective, and non-randomized, following patients who have received these devices. Participants in this registry have been or will be implanted with the AVEIR VR LP or AVEIR AR LP devices, either individually or used together. The study monitors the devices over time, focusing on their safety and effectiveness up to 24 months after implantation. Secondary measures include tracking device stimulation thresholds, detection, atrioventricular synchronization, and remaining service life over 36 months. The study involves no experimental treatments but follows real-world use of these leadless pacemakers. During the study, patient data and device performance are collected and monitored regularly for up to three years after implantation. Researchers evaluate safety and effectiveness outcomes and gather detailed patient and device information. Participants are followed to confirm how well the devices work and to monitor any changes or issues over time. The total participation duration can extend to 36 months after device implantation, allowing long-term observation of device function and patient status.

CONDITIONS

Brief Title

A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

The patient has been or will be implanted with device AVEIR VR LP and/or device AVEIR AR LP
Patient over 18 years old
Patient informed of the nature of the study, agrees to participate in the study

You will not qualify if you...

Patient under 18 years of age
Patient refusing to participate in the study

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 36 months after implantation

Participants who have been implanted with the AVEIR VR LP and/or AVEIR AR LP devices are observed to monitor the safety and effectiveness of the devices over time.

Regular follow-up visits during the 36 months after implantation