A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
ConditionPacemaker
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFrench Cardiology Society
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient under 18 years of age
Patient refusing to participate in the study
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Subject is going to or has been implanted with an AVEIR VR LP device and/or an AR LP device
Trial outcomes
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.
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)
Time frame
during 24 months after implantation2
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
Time frame
during 24 months after implantation3
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
Time frame
during 24 months after implantationSecondary 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
Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France
Time frame
during 36 months after implantation2
Monitoring of stimulation thresholds for the AVEIR VR LP VVI®, AR LP AAI® and DDD® devices.
Time frame
during 36 months after implantation3
Monitoring of AVEIR VR LP VVI® , AR LP AAI® and DDD® device detection
Time frame
during 36 months after implantation4
Monitoring the A-V synchronisation of device DDD®
Time frame
during 36 months after implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
French Cardiology Society
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov