Actively Recruiting
A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
Led by French Cardiology Society · Updated on 2026-03-09
1000
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
Sponsors
F
French Cardiology Society
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and agrees to participate
You will not qualify if you...
- Patient under 18 years of age
- Patient refusing to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chu de Grenoble - Hopital Michallon
La Tronche, France, 38700
Actively Recruiting
Research Team
P
Pascal DEFAYE
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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