Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
NCT ID: NCT02644330
Last Updated: 2015-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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surgical group
The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass
surgical repair
surgical repair with cardiopulmonary bypass
closure group
The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.
transthoracic device closure
minimally invasive transthoracic device closure
Interventions
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transthoracic device closure
minimally invasive transthoracic device closure
surgical repair
surgical repair with cardiopulmonary bypass
Eligibility Criteria
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Inclusion Criteria
* Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm
Exclusion Criteria
* Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
* Patients with severe pulmonary hypertension in right-to-left shunt
* Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
* Infective endocarditis, and heart cavity neoplasm
* Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period
3 Months
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Pan Xiangbin
Associate chief physician in pediatric cardiac surgery
Principal Investigators
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Xiangbin Pan, Dr
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Henan Province People's Hospital
Zhengzhou, Henan, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Central Contacts
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Other Identifiers
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2015-ZH39
Identifier Type: -
Identifier Source: org_study_id