Recruiting NCT06262295

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

— Observational Pacemaker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Pacemaker. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

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]
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]
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]

Secondary outcome measures (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 [Time frame: during 36 months after implantation]
Monitoring of stimulation thresholds for the AVEIR VR LP VVI®, AR LP AAI® and DDD® devices. [Time frame: during 36 months after implantation]
Monitoring of AVEIR VR LP VVI® , AR LP AAI® and DDD® device detection [Time frame: during 36 months after implantation]
Monitoring the A-V synchronisation of device DDD® [Time frame: during 36 months after implantation]
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]
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]
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]
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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 1 center

Chu de Grenoble - Hopital Michallon — La Tronche

Publications

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. 202 PMID 34455430
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 22182495
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 24347317
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 24664277
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 25881930

Identifiers

NCT: NCT06262295 · 2023-A02475-40

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗