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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pacemaker

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Pascal DEFAYE; Phone Number: +33 (0)4 76 76 50 48; Email: PDefaye@chu-grenoble.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • CHU de Grenoble - Hôpital Michallon
    • Contact: Pascal Defaye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France	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
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 36 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 36 months after implantation
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 36 months after implantation

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Collaborators: Abbott
• Investigators: Principal Investigator: Pascal DEFAYE, Chu Grenoble Alpes

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pacemaker; Leadless stimulator
• Other Study ID Numbers: 2023-A02475-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No