Surgical Valvuloplasty for Congenital Mitral Insufficiency

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03567668
• Other study ID #: TedaICH-MVP
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 8618801281613
• Email: dr.hongliu[@]foxmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Mitral Insufficiency
• Mitral Valve Insufficiency
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	TEDA International Cardiovascular Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Hong Liu

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival	recurrence-free survival is defined as free of more than moderate mitral valve regurgitation	Postoperatively; until five years after initial operation
Secondary	Postoperative complications	All postoperative complications and their treatment will be registered.	Postoperatively, until one month after initial operation