NCT06262295 A Safety and Effectiveness Monitoring in France for AVEIR VR LP and AVEIR AR LP (France LEADLESS)
| NCT ID | NCT06262295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | French Cardiology Society |
| Condition | Pacemaker |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-02-14 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Pascal DEFAYE
PRINCIPAL INVESTIGATOR
CHU Grenoble Alpes
Frequently Asked Questions
Who can join the NCT06262295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pacemaker. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06262295 currently recruiting?
Yes, NCT06262295 is actively recruiting participants. Contact the research team at PDefaye@chu-grenoble.fr for enrollment information.
Where is the NCT06262295 trial being conducted?
This trial is being conducted at La Tronche, France.
Who is sponsoring the NCT06262295 clinical trial?
NCT06262295 is sponsored by French Cardiology Society. The principal investigator is Pascal DEFAYE at CHU Grenoble Alpes. The trial plans to enroll 1,000 participants.