Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01811537
Status:
UNKNOWN
Last Update Posted:
2013-03-14
First Post:
2013-03-12
Brief Title:
Safety and Efficacy Study of a New Device for Making Neochordae in Mitral Valve Repair
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Phase II Study of Using a New Device Neochordameter in Making Artificial Chordae for Mitral Valve Repair
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
ENROLLING_BY_INVITATION
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:
Mitral prolapse is a common cardiac disease whose patients are at higher risk for serious complications Mitral valve MV repair offers several important advantages compared with valve replacement and it achieves excellent midterm and long-term results Two major problems of using pre-measured expanded polytetrafluoroethyleneePTFE neochordae the loop technique are deciding the length of the neochordae and tying the knot at the intended length Therefore a great need still exists to find new method to simplify and precise the length of neochordae 20 patients with mitral valve prolapse who undergo mitral valve repair using neochorda will be recruited in this study Trans thoracic echocardiography TTE will be done preoperatively for all patients Two three and four chamber view of each patient will be pre-operatively recorded The device will be set with extracted measurements Artificial corda loops are made using CV-4 ePTFE sutures After artificial chordae replacement the ring annuloplasty will be done Follow up A leakage test after attaching the 1st loop Post operative trans esophageal echocardiography TEE and determining the severity of mitral regurgitation Wall motion Score Index WMSI Mitral Annulus Area MAA LVEF End Systolic Volume ESV End Diastolic Volume EDV Iso-Volemic Relaxation Time IVRT IVRTQE-QE Chamber Relaxation velocityMyocard relaxation velocityEE HR TEE 3 months after discharge Cross clamp time Intubation period in ICU
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