Surgical Valvuloplasty for Congenital Mitral Insufficiency

NCT03567668 | Unknown DMC

• 1 other identifier: TedaICH-MVP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Insufficiency; Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications

  Postoperatively, until one month after initial operation

Interventions

mitral valvuloplasty PROCEDURE

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.

Also known as: mitral valve repair

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Liu: lead

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

RECRUITING

Related 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.

  PMID: 24667029 BACKGROUND

MeSH Terms

Conditions

Mitral Valve Insufficiency; Pulmonary Arterial Hypertension

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Central Study Contacts

Hong Liu, MD

CONTACT

8618801281613; dr.hongliu@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: January 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

CN (1)