Minimally Invasive Transthoracic Device Closure in Perime... | NCT02644330

Studies
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect

NCT02644330

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2015Estimated

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

Perimembranous Ventricular Septal Defect

Interventions

transthoracic device closure
surgical repair

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Dec 28, 2015

First Submission Date that Met QC Criteria

Dec 30, 2015

First Posted Date

Dec 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2015

Last Update Posted Date

Dec 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pan Xiangbin, Associate chief physician in pediatric cardiac surgery, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical group	Active Comparator	The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass	Procedure: surgical repair
closure group	Experimental	The patients in Group B (closure group) underwent minimally invasive transthoracic device closure.	Procedure: transthoracic device closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transthoracic device closure	Procedure	minimally invasive transthoracic device closure	closure group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the success rate of the operation	The definition of a successful operation: shunt disappeared	index procedure (day 0)

Secondary Outcomes

Measure	Description	Time Frame
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	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangbin Pan, Dr	Contact	010-88396666		fuwaiyiyuan28@163.cpm

Overall Officials

Name	Affiliation	Role
Xiangbin Pan, Dr	Chinese Academy of Medical Sciences, Fuwai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henan Province People's Hospital	Recruiting	Zhengzhou	Henan	450003	China
XiangYa Hospital CentralSouth University

Intervention Browse Module

MeSH Terms

ID	Term
D014945	Wound Healing

Ancestor Terms

ID	Term
D012038	Regeneration
D001686	Biological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided