Pacemaker
Conditions
Keywords
Leadless stimulator, Pacemaker
Brief summary
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.
Interventions
None listed
Sponsors
French Cardiology Society
Abbott
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
| 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 | during 24 months after implantation | device longevity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | during 36 months after implantation | Exhaustive collection of all cases of patients implanted in all French centers accredited to implant leadless stimulators in France |
| 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 | during 36 months after implantation | device longevity |
| 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 | 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) |
Countries
France
Contacts
CONTACTPascal DEFAYE
PRINCIPAL_INVESTIGATORPascal DEFAYE
CHU Grenoble Alpes
Outcome results
None listed