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A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

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ClinicalTrials.gov Identifier: NCT02361008
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Collaborator:
The Third Affiliated Hospital of Nanchang University
Information provided by (Responsible Party):
Bentong Yu, The First Affiliated Hospital of Nanchang University

Tracking Information
First Submitted Date  ICMJE January 29, 2015
First Posted Date  ICMJE February 11, 2015
Last Update Posted Date February 11, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
Surgery success rate [ Time Frame: two months ]
Surgery success means that patients in both TPDC and SR group don't change their surgery type either undergo a repeat surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
Hospitalization costs [ Time Frame: 1 months ]
The hospitalization costs calculated from hospital admission to hospital discharge
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2015)
  • Length of hospital stay (post-op) [ Time Frame: 1 months ]
    Length of hospital stay refers in particular to the post-op stay in hospital.
  • Mean bleeding volume [ Time Frame: 6 hours ]
    The mean bleeding volume only referred during the procedure
  • Volume of drainage [ Time Frame: 1 weeks ]
    The volume of drainage is calculated from being moved off operating table to being pulled out drainage tube.
  • Procedure time [ Time Frame: 6 hours ]
    The procedure time is from skin cut to skin suture
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
Official Title  ICMJE TEE-guided Perventricular Device Closure Through Minithoracotomy vs Traditional Surgery Repair Via CBP in Treatment of Infundibular Ventricular Septal Defect:A Two-center Clinical Randomized Controlled Trial
Brief Summary The purpose of this study is to investigate the security and validity of transesophageal echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.
Detailed Description Ventricular septal defect(VSD) , which accounted for about 20% of all congenital heart defects (CHDs) , is among the most common congenital heart malformations,among which infundibular ventricular septal defects(IVSD) is the least common type(18%).Multiple names for IVSD are in use. They can also be labeled conal VSD, subpulmonary VSD, subarterial VSD, doubly committed VSD, intracristal VSD,or supracristal VSD. These multiple denominations are not attached to specifically different anatomic subtypes.At present, the main methods to treat the specific anatomic condition contain conventional surgical repair(SR) and transcatheter interventional closure. The former need extracorporeal circulation,thus the side effects of extracorporeal circulation are inevitable,such as on the central nervous system, respiratory system, urinary system, etc. Although the latter has the characteristics of minimally invasive, patients should be exposed in X-ray withstanding potential risk of radiation. On the other hand,there are limits with age for patients who underwent transcatheter closure because of small vessel size. Fully developed blood vessels are to reach a certain diameter, but children need be up to 3 years old or so. In addition,the aortic valve was easily injured by wire and atrioventricular block was reported.Since the surrounding structure is complicated and the defect is too high, device closure of an IVSD is difficult to succeed in transcatheter approach. Traditional repair via cardiopulmonary bypass(CBP) is widely used to treat this kind of diseases. Past decade,with the development of technology and society,TEE-guided surgical occlusion through minithoracotomy was used to treat CHDs in an increasing number of popularity,avoiding the inherent risks of cardiopulmonary bypass and radiation,etc. But it is rarely reported to treat IVSD by minimally invasive perventricular device closure without CBP.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Septal Defects, Ventricular
  • Double Outlet Right Ventricle, Noncommitted VSD
  • Double Outlet Right Ventricle, Subaortic VSD
  • Double Outlet Right Ventricle, Subpulmonary VSD
  • Supracristal Ventricular Septal Defect
Intervention  ICMJE
  • Device: TEE-guided perventricular device closure without CBP
    Perventricular device closure through minithoracotomy under the TEE-guidance without CBP.The device is an eccentric occluder made by Shanghai Shape Memory Alloy Co.,Ltd in Shanghai,China
    Other Name: TPDC
  • Procedure: Surgery repair with CBP
    Traditional surgery repair under the CBP.
    Other Name: SR
Study Arms  ICMJE
  • Experimental: TPDC group
    Patients who matched inclusion criteria and randomly divided into TPDC group underwent the TEE-guided perventricular device closure without CBP. But of them,who underwent TPDC failure during the procedure would be dropped out of the trial.
    Interventions:
    • Device: TEE-guided perventricular device closure without CBP
    • Procedure: Surgery repair with CBP
  • Experimental: SR group
    Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.
    Intervention: Procedure: Surgery repair with CBP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2015)
20121212
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

(1) patients with single IVSD indicated by TTE,without concomitant cardiac malformation, serious arrhythmia or other important non-cardiac diseases;(2) patients whose ventricular septal defects from aortic residual < 3 mm, preoperative without aortic regurgitation or only mild reflux, defect size ≤10 mm;

Exclusion Criteria:

(1) defect size > 10 mm in diameter; (2) Preoperative with above moderate aortic valve prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed consent application

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02361008
Other Study ID Numbers  ICMJE HCQ-2012-80-SXHZJH-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bentong Yu, The First Affiliated Hospital of Nanchang University
Study Sponsor  ICMJE Bentong Yu
Collaborators  ICMJE The Third Affiliated Hospital of Nanchang University
Investigators  ICMJE
Study Director: Bentong Yu, MD 1st Affiliaed Hospital of Nanchang University
PRS Account The First Affiliated Hospital of Nanchang University
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP