NCT02361008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,121,212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

January 29, 2015

Last Update Submit

February 6, 2015

Conditions

Heart Septal Defects, VentricularDouble Outlet Right Ventricle, Noncommitted VSDDouble Outlet Right Ventricle, Subaortic VSDDouble Outlet Right Ventricle, Subpulmonary VSDSupracristal Ventricular Septal Defect

Keywords

Infundibular Ventricular Septal DefectocclusionTEE-guidedasymmetric occludersurgical repair

Outcome Measures

Primary Outcomes (1)

  • Surgery success rate

    Surgery success means that patients in both TPDC and SR group don't change their surgery type either undergo a repeat surgery.

    two months

Secondary Outcomes (1)

  • Hospitalization costs

    1 months

Other Outcomes (4)

  • Length of hospital stay (post-op)

    1 months

  • Mean bleeding volume

    6 hours

  • Volume of drainage

    1 weeks

  • +1 more other outcomes

Study Arms (2)

TPDC group

EXPERIMENTAL

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 CBPProcedure: Surgery repair with CBP

SR group

EXPERIMENTAL

Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP.

Procedure: Surgery repair with CBP

Interventions

TEE-guided perventricular device closure without CBPDEVICE

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

Also known as: TPDC
TPDC group
Surgery repair with CBPPROCEDURE

Traditional surgery repair under the CBP.

Also known as: SR
SR groupTPDC group

Eligibility Criteria

Age7 Days - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (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;

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgery Building of 1st Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

MeSH Terms

Conditions

Heart Septal Defects, VentricularDouble Outlet Right VentricleBites and Stings

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTransposition of Great VesselsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Bentong Yu, MD

    1st Affiliaed Hospital of Nanchang University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Thoracic and Cardiovascular Surgery Department

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 11, 2015

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

CN(1)