- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567668
Surgical Valvuloplasty for Congenital Mitral Insufficiency
June 13, 2018 updated by: Hong Liu
Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300457
- Recruiting
- TEDA International Cardiovascular Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Postoperatively; until five years after initial operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: Postoperatively, until one month after initial operation
|
All postoperative complications and their treatment will be registered.
|
Postoperatively, until one month after initial operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 31, 2018
Study Registration Dates
First Submitted
June 13, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TedaICH-MVP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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