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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

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.

Condition or disease Intervention/treatment Phase
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 Device: TEE-guided perventricular device closure without CBP Procedure: Surgery repair with CBP Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20121212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
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.
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

Experimental: SR group
Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.
Procedure: Surgery repair with CBP
Traditional surgery repair under the CBP.
Other Name: SR




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hospitalization costs [ Time Frame: 1 months ]
    The hospitalization costs calculated from hospital admission to hospital discharge


Other Outcome Measures:
  1. Length of hospital stay (post-op) [ Time Frame: 1 months ]
    Length of hospital stay refers in particular to the post-op stay in hospital.

  2. Mean bleeding volume [ Time Frame: 6 hours ]
    The mean bleeding volume only referred during the procedure

  3. 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.

  4. Procedure time [ Time Frame: 6 hours ]
    The procedure time is from skin cut to skin suture



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT02361008


Locations
China, Jiangxi
Surgery Building of 1st Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Sponsors and Collaborators
Bentong Yu
The Third Affiliated Hospital of Nanchang University
Investigators
Study Director: Bentong Yu, MD 1st Affiliaed Hospital of Nanchang University

Responsible Party: Bentong Yu, Director of Thoracic and Cardiovascular Surgery Department, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT02361008     History of Changes
Other Study ID Numbers: HCQ-2012-80-SXHZJH-1
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Bentong Yu, The First Affiliated Hospital of Nanchang University:
Infundibular Ventricular Septal Defect
occlusion
TEE-guided
asymmetric occluder
surgical repair

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Double Outlet Right Ventricle
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Transposition of Great Vessels