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Surgical Valvuloplasty for Congenital Mitral Insufficiency

Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03567668
Enrollment
200
Registered
2018-06-26
Start date
2012-01-01
Completion date
2018-12-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency, Pulmonary Arterial Hypertension

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.

Interventions

PROCEDUREmitral 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.

Sponsors

Hong Liu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* evidence of normal or preserved left ventricular systolic function (defined as left ventricular ejection fraction \[LVEF\] \>50%); * native mitral regurgitation of grade moderate or greater; * with or without systemic-to-pulmonary shunting necessitating concomitant surgical repairs, regardless of pulmonary arterial pressure or pulmonary artery wedge pressure.

Exclusion criteria

* functional single ventricle; * rheumatic mitral diseases; * Eisenmenger syndrome; * aortopathy, transposition of the great arteries, obstructions of ventricular outflow tract, malignant arrhythmias, cardiomyopathy, microbiological identification of infective endocarditis; * a history of pericardiotomy or intervention therapy.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free survivalPostoperatively; until five years after initial operationrecurrence-free survival is defined as free of more than moderate mitral valve regurgitation

Secondary

MeasureTime frameDescription
Postoperative complicationsPostoperatively, until one month after initial operationAll postoperative complications and their treatment will be registered.

Countries

China

Contacts

Primary ContactHong Liu, MD
dr.hongliu@foxmail.com8618801281613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026