Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03470155
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2018-03-12
Brief Title:
Operative Mitral Valve Reconstruction in Functional mv Insufficiency With Reduced Systolic Ventricle Function
Sponsor:
Institut für Pharmakologie und Präventive Medizin
Organization:
Institut für Pharmakologie und Präventive Medizin
Study Overview
Official Title:
Operative Mitralklappenrekonstruktion Bei Funktionellen Mitralklappenvitien Bei Reduzierter Systolischer Ventrikelfunktion
Status:
COMPLETED
Status Verified Date:
2023-09
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:
REFORM-MR
Brief Summary:
Functional mitral insufficiency poses a challenge with regard to the optimal time of intervention particularly because they are frequently associated with left ventricular LV dilation and reduced LV ejection fraction EF The registry will document the underlying pathology by using transthoracal echo cardiography TTE with analysis of common tenting parameters OP strategies data and outcomes will be documented as well as follow-up data for echocardiography quality of life and MACCE outcomes after 6 months 1 and 2 years
Detailed Description:
Prospective enrolment of all patients with mitral valve insufficiency and restricted movement of leaflets during systole into a multicentric registry Exact analysis of the underlying pathology using TTE with analysis of tenting parameters In patients without contraindications functional preoperative MRT to determine the functional reserve of ventricular function Documentation of the quality of life of the patients using the SF12 questionnaire before and after intervention Documentation of follow-up data SF12 TTE NT-pro BNP at 6 months 1 and 2 years Development of operative strategies to improve long-term outcomes in patients with severe LV dilation typically accompanied by function mitral insufficiency type IIIb
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