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Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

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ClinicalTrials.gov Identifier: NCT02644330
Recruitment Status : Unknown
Verified December 2015 by Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.

Condition or disease Intervention/treatment Phase
Perimembranous Ventricular Septal Defect Procedure: transthoracic device closure Procedure: surgical repair Phase 2 Phase 3

Detailed Description:

Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: surgical group
The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass
Procedure: surgical repair
surgical repair with cardiopulmonary bypass

Experimental: closure group
The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.
Procedure: transthoracic device closure
minimally invasive transthoracic device closure




Primary Outcome Measures :
  1. the success rate of the operation [ Time Frame: index procedure (day 0) ]
    The definition of a successful operation: shunt disappeared


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 12 months ]
    death, cardiac perforation, cardiac tamponade, emerging tricuspid regurgitation, emerging aortic regurgitation, arrhythmias (third-degree atrioventricular block, complete bundle branch block), postoperative residual shunt (refers to the residual shunt, which diameter greater than 2mm or flow rate greater than 3m/s), infective endocarditis, postoperative murmur

  2. thoracic fluid volume [ Time Frame: index procedure (day 0) ]
  3. blood transfusion [ Time Frame: index procedure (day 0) ]
  4. operating time [ Time Frame: index procedure (day 0) ]
    time cost from cut the skin to complete closure of the sternum

  5. postoperative ventilator support time [ Time Frame: index procedure (day 0) ]
  6. postoperative hospital stay [ Time Frame: 7 days after operation or before discharge ]
  7. costs [ Time Frame: 7 days after operation or before discharge ]


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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥3 months
  • Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm

Exclusion Criteria:

  • Para adverse ventricular septal defect
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644330


Contacts
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Contact: Xiangbin Pan, Dr 010-88396666 fuwaiyiyuan28@163.cpm

Locations
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China, Henan
Henan Province People's Hospital Recruiting
Zhengzhou, Henan, China, 450003
China, Hunan
XiangYa Hospital CentralSouth University Recruiting
Changsha, Hunan, China, 410008
China, Yunnan
The First Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiangbin Pan, Dr Fuwai Hospital

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Responsible Party: Pan Xiangbin, Associate chief physician in pediatric cardiac surgery, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT02644330     History of Changes
Other Study ID Numbers: 2015-ZH39
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities