Atrial Septal DefectNCT04096924
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
A study testing Guidewire for echo-guided interventions and Cook lunderquist guidewire in people with Atrial Septal Defect, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atrial Septal Defect
- What is being tested?
- Guidewire for echo-guided interventions and Cook lunderquist guidewire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 7 Jul 2018to 30 May 2020
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart.
- edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve.
- diameter of atrial septal > left-atrium-side diameter of occlude.
- participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form.
Who cannot join
- Primary atrial septal defect.
- Sinus venosus atrial septal defects.
- Accompany with endocarditis or hemorrhagic risks.
- thrombosis in targeting area or venous thrombosis in inserting site.
- severe pulmonary artery hypertension generated right-to-left shunt.
- severe myocardial or valve disease unrelated with ASD.
- suffered infection diseases or developing infection diseases within 1 month, thrombosis in left atrium or left appendage, part or total anomalous pulmonary venous drainage.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 2 recruiting
- Recruiting
Structural Heart Disease Center, Fuwai Hospital
Beijing, Beijing Municipality
Xiangbin Pan, MD,Ph.D, 010-88396666, xiangbin428@hotmail.com
- Active, not recruiting
Xinjiang People's Hospital
Ürümqi, Xinjiang
- Not yet recruiting
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan
Taibin Fan, MD, Ph.D
About this study
Official title: A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.
Read the detailed description
- This is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided interventions designed by Hangzhou Dexin Medical Technological Company with other similar products.
- This trial will enroll about 100 subjects from 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). Proposal recruiting period is 18 months and follow-up will be performed for 30 days.
- Conditions
- Atrial Septal Defect
- Being tested
- Guidewire for echo-guided interventions, Cook lunderquist guidewire
- Keywords
- ASD, Atrial septal defects, amplatzer
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidewire for echo-guided interventionsDevice
Under echocardiography guided treatment of ASD with a novel interventional guidewire
Cook lunderquist guidewireDevice
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD. Receives: Device: Guidewire for echo-guided interventions |
| Control Group | Active comparator | Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD. Receives: Device: Cook lunderquist guidewire |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
The primary outcome will be the success rate, which is defined by the principles below:
- guidewire can successfully access to left atrium through ASD.
- sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout.
- guidewire can be successfully pulled out. The secondary outcome will be duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels.
Measured: Immediately after treatment
Secondary outcomes (1)
Incidence of major adverse events(MAE)
MAE definition: Any complications related to devices or surgeries, including but not limited to: death, emergency surgery, severe cardiac tamponade requiring pericardiocentesis or operation, hemorrhage, stroke related to operation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start7 Jul 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial 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 N/A
- 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, MD,Ph.D, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096924
- Sponsor's protocol ID
- HYQ001
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong P, Zhao G, Zhang Z, Zhang W, Fan T, Han Y, Pang K, Wang S, Zhang F, Wang W, Hu S, Pan X. Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009281. doi: 10.1161/CIRCINTERVENTIONS.120.009281. Epub 2020 Aug 27.
PubMed 32847382
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD
- ClinicalTrials.gov ID
- NCT04096924
- Acronym / sponsor ID
- HYQ001
- Conditions
- Atrial Septal Defect
- Keywords
- ASD, Atrial septal defects, amplatzer
- 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
- 7 Jul 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 20 Sep 2019 (actual)
- 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.
Prospective randomized multicenter trial of about 100 subjects enrolled in 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). To precise the function of this device on reducing technical difficulties and conquering learning curves, it is required that the doctor should be able to independently do echo-guided percutaneous interventions and his cases should be more than 20 but less than 100. Experimental group is allocated to use novel interventional guidewire for echocardiography guided percutaneous interventions for ASD, control group will be treated by cook lunderquist guidewire. If echo-guided procedure does not work well, the procedure will be immediately replaced by conventional procedure guided by radiology. To evaluate the effectiveness and safety comprehensively, variables are defined as success rate, duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels etc.
Detailed description
- This is a prospective blinded randomized multicenter comparison clinical trial followed the design of superiority trial to compare the effectiveness and safety of the guidewire for echo-guided interventions designed by Hangzhou Dexin Medical Technological Company with other similar products.
- This trial will enroll about 100 subjects from 3-5 centers. Patients will be randomized to two groups in equal proportion (50 in each). Proposal recruiting period is 18 months and follow-up will be performed for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Guidewire for echo-guided interventionsExperimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD. |
| Control Group | Active comparator | Device: Cook lunderquist guidewireControl Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age≥2yrs, diameter of defect≥5 mm, central ASD with increased volume load of right heart.
- edge of defect is ≥5 mm from coronary sinus, superior and inferior vena cava, and pulmonary vein, and≥7 mm from atrioventricular valve.
- diameter of atrial septal > left-atrium-side diameter of occlude.
- participants or guardians who can understand the purpose of this trial and voluntarily participate in and sign the informed consent form.
Key exclusion criteria (7 listed)
- Primary atrial septal defect.
- Sinus venosus atrial septal defects.
- Accompany with endocarditis or hemorrhagic risks.
- thrombosis in targeting area or venous thrombosis in inserting site.
- severe pulmonary artery hypertension generated right-to-left shunt.
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 |
|---|---|---|
| Guidewire for echo-guided interventionsUnder echocardiography guided treatment of ASD with a novel interventional guidewire | Device | Treatment Group |
| Cook lunderquist guidewireSubjects with ASD treated with amplatzer using the Cook lunderquist guidewire. | Device | Control Group |
Primary outcome
success rate
Time frame: Immediately after treatment
The primary outcome will be the success rate, which is defined by the principles below: 1. guidewire can successfully access to left atrium through ASD. 2. sheath can successfully access to left atrium guided by guidewire and not fall into right atrium after guidewire pullout. 3. guidewire can be successfully pulled out. The secondary outcome will be duration of procedure, times of arrhythmia, times of misguided to tricuspid valve, cardiac perforation, cardiac tamponed, complications in peripheral vessels.
1 secondary outcome
Incidence of major adverse events(MAE)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 32847382Kong P, Zhao G, Zhang Z, Zhang W, Fan T, Han Y, Pang K, Wang S, Zhang F, Wang W, Hu S, Pan X. Novel Panna Guide Wire Facilitates Percutaneous and Nonfluoroscopic Procedure for Atrial Septal Defect Closure: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Sep;13(9):e009281. doi: 10.1161/CIRCINTERVENTIONS.120.009281. Epub 2020 Aug 27.
- Individual participant dataSharing planned: No
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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.
Xiangbin Pan, MD,Ph.D 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 study testing Guidewire for echo-guided interventions and Cook lunderquist guidewire in people with Atrial 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 4 inclusion and 7 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 20 Sep 2019. 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.
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, MD,Ph.D (010-88396666, xiangbin428@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: Immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096924, which also lists 1 linked publication.
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 20 Sep 2019.