Sponsor study identifier
interventional
100
1 country
3
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 28, 2015
Actual (reported)December 31, 2015
Actual (reported)October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
the success rate of the operation
The definition of a successful operation: shunt disappeared
index procedure (day 0)
adverse events
12 months
thoracic fluid volume
index procedure (day 0)
blood transfusion
index procedure (day 0)
operating time
index procedure (day 0)
postoperative ventilator support time
index procedure (day 0)
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.
minimally invasive transthoracic device closure
surgical repair with cardiopulmonary bypass
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Henan Province People's Hospital
Zhengzhou, Henan, 450003, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, 410008, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Xiangbin Pan, Dr
Chinese Academy of Medical Sciences, Fuwai Hospital
First Submitted
December 28, 2015
First Posted
December 31, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
French Registry Conducted on E-vita OPEN NEO
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 31, 2015
Record last verified: 2015-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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