Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-03-08 @ 4:26 AM
Study NCT ID:
NCT03567668
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2018-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Valvuloplasty for Congenital Mitral Insufficiency
Sponsor:
Hong Liu
Organization:
Study Overview
Official Title:
Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
RECRUITING
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:
Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: