Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465459
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-29
Brief Title:
Post-marketing Clinical Study of the LAMBRE System for Left Auricle Closure
Sponsor:
French Cardiology Society
Organization:
French Cardiology Society
Study Overview
Official Title:
ESCALLE Post-marketing Clinical Study of the LambrE System for Left Auricle Closure
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:
ESCALLE
Brief Summary:
Atrial fibrillation AF is responsible for 15-20 of ischaemic strokes These events are often caused by thrombus formation in the left atrium Thromboembolic risk in AF is primarily prevented by oral anticoagulation However this drug-based approach has a number of limitations the most important of which are compliance problems and above all the risk of haemorrhagic complications some of which are potentially serious Left atrial appendage closure is a therapeutic alternative for the prevention of cardioembolic risk in cases where anticoagulation is clearly contraindicated
The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE LIFETCH prosthesis a device for transcatheter closure of the left atrial appendage is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score 4 and a formal and permanent contraindication to anticoagulants validated by a multidisciplinary committee
LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee Among the criteria analysed regarding the efficacy and safety of the device implantation the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration
The CNEDiMTS opinion of 12 March 2019 defines that the LAMBRE LIFETCH prosthesis a device for transcatheter closure of the left atrial appendage is authorised for the prevention of thromboembolic events in patients with non-valvular atrial fibrillation at high risk of thromboembolic events with a CHA2DS2-VASc score 4 and a formal and permanent contraindication to anticoagulants validated by a multidisciplinary committee
LAMBRE prosthesis in France are subject to a review of the results by the CNEDIMTS committee Among the criteria analysed regarding the efficacy and safety of the device implantation the result regarding the migration rate of the LAMBRE device will be one of the criteria enabling the Commission to decide on the appropriateness of the renewal of the registration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None