Chu de Grenoble - Hopital Michallon
La Tronche, 38700, France
Location status: Recruiting
Location contact
Pascal DEFAYE
CONTACT
NCT Number: NCT06262295
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
La Tronche, 38700, France
Location status: Recruiting
Pascal DEFAYE
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: during 24 months after implantation
device longevity
Time frame: during 24 months after implantation
electrical performance of the device
Time frame: during 36 months after implantation
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 implantation
Time frame: during 36 months after implantation
Time frame: during 36 months after implantation
Time frame: 1 year, 2 years and 3 years after implantation
Time frame: during 36 months after implantation
device longevity
Time frame: during 36 months after implantation
electrical performance of the device
Time frame: during 36 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)
Contact information is provided by the study sponsor or research team.
French Cardiology Society
Other
France LEADLESS, A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP
Acronym: FranceLEADLESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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