Skip to main content
Clinical Trials/NCT03567668
NCT03567668
Unknown
Not Applicable

Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

Hong Liu1 site in 1 country200 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Insufficiency
Sponsor
Hong Liu
Enrollment
200
Locations
1
Primary Endpoint
Recurrence-free survival
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hong Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Hong Liu

Clinical Investigator

Nanjing Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Recurrence-free survival

Time Frame: Postoperatively; until five years after initial operation

recurrence-free survival is defined as free of more than moderate mitral valve regurgitation

Secondary Outcomes

  • Postoperative complications(Postoperatively, until one month after initial operation)

Study Sites (1)

Loading locations...

Similar Trials