Perimembranous Ventricular Septal DefectPhase 2/3NCT02644330
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
A Phase 2/3 study testing transthoracic device closure and surgical repair in people with Perimembranous Ventricular Septal Defect, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Perimembranous Ventricular Septal Defect
- What is being tested?
- transthoracic device closure and surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 2/3
- 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age≥3 months
- Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm
Who cannot join
- Para adverse ventricular septal defect
- Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
- Patients with severe pulmonary hypertension in right-to-left shunt
- Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
- Infective endocarditis, and heart cavity neoplasm
- Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
XiangYa Hospital CentralSouth University
Changsha, Hunan, 410008
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
- Recruiting
Henan Province People's Hospital
Zhengzhou, Henan, 450003
About this study
Official title: A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
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.
Read the detailed description
Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .
Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.
- Conditions
- Perimembranous Ventricular Septal Defect
- Being tested
- transthoracic device closure, surgical repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic device closureProcedure or surgery
minimally invasive transthoracic device closure
surgical repairProcedure or surgery
surgical repair with cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| surgical group | Active comparator | The patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass Receives: Procedure: surgical repair |
| closure group | Experimental | The patients in Group B (closure group) underwent minimally invasive transthoracic device closure. Receives: Procedure: transthoracic device closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of the operation
The definition of a successful operation: shunt disappeared
Measured: index procedure (day 0)
Secondary outcomes (7)
adverse events
death, cardiac perforation, cardiac tamponade, emerging tricuspid regurgitation, emerging aortic regurgitation, arrhythmias (third-degree atrioventricular block, complete bundle branch block), postoperative residual shunt (refers to the residual shunt, which diameter greater than 2mm or flow rate greater than 3m/s), infective endocarditis, postoperative murmur
Measured: 12 months
thoracic fluid volume
Measured: index procedure (day 0)
blood transfusion
Measured: index procedure (day 0)
operating time
time cost from cut the skin to complete closure of the sternum
Measured: index procedure (day 0)
postoperative ventilator support time
Measured: index procedure (day 0)
postoperative hospital stay
Measured: 7 days after operation or before discharge
costs
Measured: 7 days after operation or before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimembranous Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, Dr, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644330
- Sponsor's protocol ID
- 2015-ZH39
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT02644330
- Acronym / sponsor ID
- 2015-ZH39
- Conditions
- Perimembranous Ventricular Septal Defect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 31 Dec 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 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.
Detailed description
Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .
Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical group | Active comparator | Procedure: surgical repairThe patients in Group A (surgical group) underwent surgical repair with cardiopulmonary bypass |
| closure group | Experimental | Procedure: transthoracic device closureThe patients in Group B (closure group) underwent minimally invasive transthoracic device closure. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age≥3 months
- Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm
Key exclusion criteria (6 listed)
- Para adverse ventricular septal defect
- Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
- Patients with severe pulmonary hypertension in right-to-left shunt
- Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
- Infective endocarditis, and heart cavity neoplasm
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 |
|---|---|---|
| transthoracic device closureminimally invasive transthoracic device closure | Procedure or surgery | closure group |
| surgical repairsurgical repair with cardiopulmonary bypass | Procedure or surgery | surgical group |
Primary outcome
the success rate of the operation
Time frame: index procedure (day 0)
The definition of a successful operation: shunt disappeared
7 secondary outcomes
adverse events
Time frame: 12 months
thoracic fluid volume
Time frame: index procedure (day 0)
blood transfusion
Time frame: index procedure (day 0)
operating time
Time frame: index procedure (day 0)
postoperative ventilator support time
Time frame: index procedure (day 0)
postoperative hospital stay
Time frame: 7 days after operation or before discharge
costs
Time frame: 7 days after operation or before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
Related trials for Perimembranous Ventricular Septal Defect
RecruitingObservational study
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Perimembranous Ventricular Septal Defect
RecruitingObservational study
A Multimodal AI Prediction Model for Complications After Transcatheter Closure of Perimembranous VSD in Children
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
Active, not recruitingObservational study
Early Warning of Structural Complications in Perimembranous VSD
Congenital Heart Disease (CHD), Ventricular Septal Defects (VSD)
Not yet recruitingObservational study
Use of TEE Derived Measurement vs Direct Measurement Under General Anesthesia in Assessment of Pressure Gradient in Peri Membranous Ventricular Septal Defect
Peri Membranous Ventricular Septal Defect
Active, not recruitingObservational study
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
Perimembranous Ventricular Septal Defect
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.
Xiangbin Pan, Dr principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transthoracic device closure and surgical repair in people with Perimembranous Ventricular Septal Defect, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, Dr (010-88396666, fuwaiyiyuan28@163.cpm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of the operation (time frame: index procedure (day 0)). 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 31 Dec 2015.