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National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS)

Pacemaker Clinical Trial

Official title:
France LEADLESS, Comprehensive Follow-up of the Leadless Stimulator AVEIR VR LP

Clinical Trial Summary

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. The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe. The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06262295
Study type Observational [Patient Registry]
Source French Cardiology Society
Contact Pascal DEFAYE
Phone (0)4 76 76 50 48
Email PDefaye@chu-grenoble.fr
Status Not yet recruiting
Phase
Start date February 2024
Completion date September 2027
View Details
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