NCT06262295

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Feb 2024Sep 2029

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

February 6, 2024

Last Update Submit

March 6, 2026

Conditions

Pacemaker

Keywords

Leadless stimulatorPacemaker

Outcome Measures

Primary Outcomes (3)

  • 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.

    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)

    during 24 months after implantation

  • 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

    device longevity

    during 24 months after implantation

  • 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

    electrical performance of the device

    during 24 months after implantation

Secondary Outcomes (8)

  • 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

    during 36 months after implantation

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

    during 36 months after implantation

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

    during 36 months after implantation

  • Monitoring the A-V synchronisation of device DDD®

    during 36 months after implantation

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

    1 year, 2 years and 3 years after implantation

  • +3 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be included in cardiology departments participating in the study. 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Grenoble - Hopital Michallon

La Tronche, 38700, France

RECRUITING

Related Publications (5)

  • Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.

    PMID: 34455430BACKGROUND

  • Udo EO, Zuithoff NP, van Hemel NM, de Cock CC, Hendriks T, Doevendans PA, Moons KG. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012 May;9(5):728-35. doi: 10.1016/j.hrthm.2011.12.014. Epub 2011 Dec 17.

    PMID: 22182495BACKGROUND

  • Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.

    PMID: 24347317BACKGROUND

  • Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.

    PMID: 24664277BACKGROUND

  • Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.

    PMID: 25881930BACKGROUND

Study Officials

  • Pascal DEFAYE

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal DEFAYE

CONTACT

(0)4 76 76 50 48PDefaye@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 16, 2024

Study Start

February 14, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

FR(1)