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Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

Primary Purpose

Perimembranous Ventricular Septal Defect

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
transthoracic device closure
surgical repair
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perimembranous Ventricular Septal Defect

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henan Province People's HospitalRecruiting
  • XiangYa Hospital CentralSouth UniversityRecruiting
  • The First Affiliated Hospital of Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

surgical group

closure group

Arm Description

The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass

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

Outcomes

Primary Outcome Measures

the success rate of the operation
The definition of a successful operation: shunt disappeared

Secondary Outcome Measures

adverse events
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
thoracic fluid volume
blood transfusion
operating time
time cost from cut the skin to complete closure of the sternum
postoperative ventilator support time
postoperative hospital stay
costs

Full Information

First Posted
December 28, 2015
Last Updated
December 30, 2015
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02644330
Brief Title
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
Official Title
A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perimembranous Ventricular Septal Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical group
Arm Type
Active Comparator
Arm Description
The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass
Arm Title
closure group
Arm Type
Experimental
Arm Description
The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.
Intervention Type
Procedure
Intervention Name(s)
transthoracic device closure
Intervention Description
minimally invasive transthoracic device closure
Intervention Type
Procedure
Intervention Name(s)
surgical repair
Intervention Description
surgical repair with cardiopulmonary bypass
Primary Outcome Measure Information:
Title
the success rate of the operation
Description
The definition of a successful operation: shunt disappeared
Time Frame
index procedure (day 0)
Secondary Outcome Measure Information:
Title
adverse events
Description
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
Time Frame
12 months
Title
thoracic fluid volume
Time Frame
index procedure (day 0)
Title
blood transfusion
Time Frame
index procedure (day 0)
Title
operating time
Description
time cost from cut the skin to complete closure of the sternum
Time Frame
index procedure (day 0)
Title
postoperative ventilator support time
Time Frame
index procedure (day 0)
Title
postoperative hospital stay
Time Frame
7 days after operation or before discharge
Title
costs
Time Frame
7 days after operation or before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Pan, Dr
Phone
010-88396666
Email
fuwaiyiyuan28@163.cpm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, Dr
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Province People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Name
XiangYa Hospital CentralSouth University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

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