Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead. This french Registry "France LEADLESS" is a national registry designed to confirm the safety and efficacy of the AVEIR VR LP System in a patient population indicated for the implantation of a VVI(R) pacemaker in France and the AVEIR AR LP System in a population of patients indicated for the implantation of an AAI(R) pacemaker or both systems used in conjunction in a population of patients indicated for the implantation of a DDD(R) pacemaker. This registry will also make it possible to collect the characteristics and indications of patients under normal conditions of use.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
To confirm the safety of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device.
Timeframe: during 24 months after implantation
To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device
Timeframe: during 24 months after implantation
To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device
Timeframe: during 24 months after implantation