- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096924
A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
September 18, 2019 updated by: Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiangbin Pan, MD,Ph.D
- Phone Number: 010-88396666
- Email: xiangbin428@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Structural Heart Disease Center, Fuwai Hospital
-
Contact:
- Xiangbin Pan, MD,Ph.D
- Phone Number: 010-88396666
- Email: xiangbin428@hotmail.com
-
-
Henan
-
Zhengzhou, Henan, China
- Not yet recruiting
- Fuwai Huazhong Cardiovascular Hospital
-
Contact:
- Taibin Fan, MD, Ph.D
-
-
Xinjiang
-
Urumqi, Xinjiang, China
- Active, not recruiting
- Xinjiang People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.
|
Under echocardiography guided treatment of ASD with a novel interventional guidewire
|
Active Comparator: Control Group
Control Group is allocated to use Cook lunderquist guidewire for the echocardiography guided percutaneous interventions for ASD.
|
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate
Time Frame: Immediately after treatment
|
The primary outcome will be the success rate, which is defined by the principles below:
|
Immediately after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of major adverse events(MAE)
Time Frame: 1 month
|
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.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiangbin Pan, MD,Ph.D, Chinese Academy of Medical Sciences, Fuwai Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2018
Primary Completion (Anticipated)
December 30, 2019
Study Completion (Anticipated)
May 30, 2020
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYQ001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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