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

NCT06262295 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-03-09

No results posted yet for this study

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.

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

  • Pacemaker

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Pascal DEFAYE · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06262295 on ClinicalTrials.gov