National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS)

February 14, 2024 updated by: French Cardiology Society

France LEADLESS, Comprehensive Follow-up of the Leadless Stimulator AVEIR VR 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.

The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.

The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. The study may be offered to any patient undergoing an implantation of leadless pacemaker using AVEIR VR LP device in France.

Description

Inclusion Criteria:

  • Patient implanted with an AVEIR VR LP device
  • 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

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Implantation of the pacemaker without lead AVEIR VR LP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To confirm the safety of the AVEIR VR LP 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)
during 24 months after implantation
To confirm the effectiveness of the AVEIR VR LP device
Time Frame: during 24 months after implantation
device longevity and electrical performance as assessed by stimulation threshold, % stimulation, impedance and amplitudes of R waves in the zone therapeutic
during 24 months after implantation
To collect patient characteristics and indications in normal conditions of use of the AVEIR VR LP device
Time Frame: during 24 months after implantation
Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France
during 24 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

Abbott

Investigators

  • Principal Investigator: Pascal DEFAYE, Chu Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

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)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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