NCT03567668

Surgical Valvuloplasty for Congenital Mitral Insufficiency

Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hong Liu · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Insufficiency
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
PROCEDURE	mitral valvuloplasty	Commissural plication was the most commonly used technique to repair mitral insufficiency, which was selectively supplemented by a specific combination of one or more of the following procedures: cleft closure, chordal shortening, transposition or replacement, edge-to-edge repair, leaflet augmentation, or division of papillary muscles, depending on the individual etiology and anatomy.

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-06-26
• Last updated: 2018-06-26

Locations

1 site across 1 country: China