Recruiting

France LEADLESFrance LEADLESS, a Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP

What is being collected

Data Collection

Who is being recruted

Over 18 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: February 2024

See protocol details

Summary

Principal SponsorFrench Cardiology Society

Study ContactPascal DEFAYE

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 14, 2024

Actual date on which the first participant was enrolled.

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.

Official TitleFrance LEADLESS, a Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP

NCT06262295

Principal SponsorFrench Cardiology Society

Study ContactPascal DEFAYE

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

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

2 exclusion criteria prevent from participating

Patient under 18 years of age

Patient refusing to participate in the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Chu de Grenoble - Hopital Michallon

La Tronche, FranceOpen Chu de Grenoble - Hopital Michallon in Google Maps

Recruiting

One Study Center