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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-14

Study Completion Date

2028-09-14

Brief Summary

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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.

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Detailed Description

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Observational national multicentric registry. Retrospective and Prospective, non-randomized, single-arm allowing exhaustive follow up of all AVEIR VR and AR LP implants in France.

Conditions

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Pacemaker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Subject is going to or has been implanted with an AVEIR VR LP device and/or an AR LP device

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient implanted with an AVEIR VR LP device and/or an AR LP device
* Patient over 18 years old
* Patient informed of the nature of the study, agrees to participate in the study