Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634121
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Efficacy of MitraCLip Vs PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Mitraclip Vs PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEAFLET I
Brief Summary:
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting
Detailed Description:
In the context of M-TEER two different systems MitraClip vs PASCAL are CE certified and clinically available In the case of non-complex anatomy both systems are comparable in terms of effectiveness Whether this holds true in cases of complex or highly complex anatomy in an Allcomer patient population is currently unclear
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