Ignite Creation Date:
2024-05-06 @ 10:29 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03271762
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2017-08-25
Brief Title:
Multicentre Study of MITRACLIP Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Multicentre and Randomized Study of MITRACLIP Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MITRA-HR
Brief Summary:
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip or mitral valve surgery with high surgical risk
This trial is a French and Monegasque multicenter and randomized trial Patients enrolled will be clinically followed for 2 years clinical visit at 1 month at 6 months and 12 months phone call at 18 months and clincial visit at 24 months
This trial is a French and Monegasque multicenter and randomized trial Patients enrolled will be clinically followed for 2 years clinical visit at 1 month at 6 months and 12 months phone call at 18 months and clincial visit at 24 months
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