Clinical trial NCT03567668: Surgical Valvuloplasty for Congenital Mitral Insufficiency
Official title: Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Insufficiency
Pulmonary Arterial Hypertension
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The infants and young children aged 5 months to 15 years are eligible for enrolment in this study if they had echocardiography confirmed mitral insufficiency.

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.


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.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: Postoperatively; until five years after initial operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: Postoperatively, until one month after initial operation
Other outcomes:
Locations:
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
state: Tianjin
Study officials:
References:
citation: Kalfa D, Vergnat M, Ly M, Stos B, Lambert V, Baruteau A, Belli E. A standardized repair-oriented strategy for mitral insufficiency in infants and children: midterm functional outcomes and predictors of adverse events. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1459-66. doi: 10.1016/j.jtcvs.2014.02.057. Epub 2014 Feb 26.