Heart Septal Defects, VentricularNCT02361008
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
A study testing TEE-guided perventricular device closure without CBP and Surgery repair with CBP in people with Heart Septal Defects, Ventricular and Double Outlet Right Ventricle, Noncommitted VSD, run by Bentong Yu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 70 years
- Conditions the study is for
- Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD, Double Outlet Right Ventricle, Subaortic VSD
- What is being tested?
- TEE-guided perventricular device closure without CBP and Surgery repair with CBP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,121,212 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Surgery Building of 1st Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
About this study
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
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.
Read the 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.
- Conditions
- 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
- Being tested
- TEE-guided perventricular device closure without CBP, Surgery repair with CBP
- Keywords
- Infundibular Ventricular Septal Defect, occlusion, TEE-guided, asymmetric occluder, surgical repair
- Medical subject headings
- Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEE-guided perventricular device closure without CBPDevice
Also called TPDC
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
Surgery repair with CBPProcedure or surgery
Also called SR
Traditional surgery repair under the CBP.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TEE-guided perventricular device closure without CBP; Procedure: Surgery repair with CBP |
| SR group | Experimental | Patients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP. Receives: Procedure: Surgery repair with CBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Secondary outcomes (1)
Hospitalization costs
The hospitalization costs calculated from hospital admission to hospital discharge
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Septal Defects, VentricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20,121,212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bentong Yu
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor-investigator, Bentong Yu, The First Affiliated Hospital of Nanchang University
- Investigators
- Bentong Yu, MD, Study director, 1st Affiliaed Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361008
- Sponsor's protocol ID
- HCQ-2012-80-SXHZJH-1
- Status last verified
- Feb 2015
- First submitted
- 29 Jan 2015
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02361008
- Acronym / sponsor ID
- HCQ-2012-80-SXHZJH-1
- Conditions
- 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
- Keywords
- Infundibular Ventricular Septal Defect, occlusion, TEE-guided, asymmetric occluder, surgical repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,121,212 participants (actual)
- Lead sponsor
- Bentong YuUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Nanchang University
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPDC group | Experimental | Device: TEE-guided perventricular device closure without CBP, Procedure: Surgery repair with CBPPatients 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. |
| SR group | Experimental | Procedure: Surgery repair with CBPPatients who matched inclusion criteria and randomly assigned into SR group underwent the surgery repair with CBP. |
Who may qualify
- Ages
- 7 days to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEE-guided perventricular device closure without CBPAlso: TPDCPerventricular 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 | Device | TPDC group |
| Surgery repair with CBPAlso: SRTraditional surgery repair under the CBP. | Procedure or surgery | SR group, TPDC group |
Primary outcome
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.
1 secondary outcome
Hospitalization costs
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bentong Yu, MD study director
1st Affiliaed Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEE-guided perventricular device closure without CBP and Surgery repair with CBP in people with Heart Septal Defects, Ventricular and Double Outlet Right Ventricle, Noncommitted VSD, run by Bentong Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery success rate (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.