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NCT Number: NCT06262295

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Grenoble - Hopital Michallon

La Tronche, 38700, France

Location status: Recruiting

Location contact

Pascal DEFAYE

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The 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, agrees to participate in the study

Exclusion criteria

  • Patient under 18 years of age
  • Patient refusing to participate in the study

Treatment and study plan

Primary outcomes

  1. To confirm the safety of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device.

    Time frame: during 24 months after implantation

    Assessed by rate of successful implantation, absence of complications (as assessed by number of procedural or device related complications) and reoperation (as assessed by number of replacement, explantation, change in device position)

  2. To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 24 months after implantation

    device longevity

  3. To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 24 months after implantation

    electrical performance of the device

Secondary outcomes

  1. To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 36 months after implantation

    Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France

  2. Monitoring of stimulation thresholds for the AVEIR VR LP VVI®, AR LP AAI® and DDD® devices.

    Time frame: during 36 months after implantation

  3. Monitoring of AVEIR VR LP VVI® , AR LP AAI® and DDD® device detection

    Time frame: during 36 months after implantation

  4. Monitoring the A-V synchronisation of device DDD®

    Time frame: during 36 months after implantation

  5. The remaining service life of AVEIR VR LP VVI®, AR LP AAI® and DDD® devices.

    Time frame: 1 year, 2 years and 3 years after implantation

  6. To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 36 months after implantation

    device longevity

  7. To confirm the effectiveness of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 36 months after implantation

    electrical performance of the device

  8. To confirm the safety of the AVEIR VR LP VVI® and AVEIR AR LP AAI® devices when used either individually or in combination with the DDD® device

    Time frame: during 36 months after implantation

    Assessed by rate of successful implantation, absence of complications (as assessed by number of procedural or device related complications) and reoperation (as assessed by number of replacement, explantation, change in device position)

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal DEFAYE

CONTACT

[email protected]

(0)4 76 76 50 48 ext. +33

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Acronym: FranceLEADLESS

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 16, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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