Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262295
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-02-06
Brief Title:
Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
France LEADLESS Comprehensive Follow-up of the Leadless Stimulator AVEIR VR LP
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 VVIR pacemaker in France This registry will also allow the collection of patient characteristics and indications under normal conditions of use
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 VVIR pacemaker in France This registry will also allow the collection of patient characteristics and indications under normal conditions of use
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None