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

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 VVI(R), AAI(R), or DDD(R) 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.

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