A Prospective Randomized Multicenter Trial of the Guidewire for Echo-guided Interventions
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|ClinicalTrials.gov Identifier: NCT04096924|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Septal Defect||Device: Guidewire for echo-guided interventions Device: Cook lunderquist guidewire||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Multicenter Comparison Trial to Evaluate the Effectiveness and Safety of the Guidewire for Echo-guided Interventions in Treating ASD|
|Actual Study Start Date :||July 7, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||May 30, 2020|
Experimental: Treatment Group
Experimental group is allocated to use novel interventional guidewire for the echocardiography guided percutaneous interventions for ASD.
Device: Guidewire for echo-guided interventions
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.
Device: Cook lunderquist guidewire
Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.
- success rate [ Time Frame: Immediately after treatment ]
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096924
|Contact: Xiangbin Pan, MD,Ph.Demail@example.com|
|Structural Heart Disease Center, Fuwai Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: Xiangbin Pan, MD,Ph.D 010-88396666 firstname.lastname@example.org|
|Fuwai Huazhong Cardiovascular Hospital||Not yet recruiting|
|Zhengzhou, Henan, China|
|Contact: Taibin Fan, MD, Ph.D|
|Xinjiang People's Hospital||Active, not recruiting|
|Urumqi, Xinjiang, China|
|Principal Investigator:||Xiangbin Pan, MD,Ph.D||Chinese Academy of Medical Sciences, Fuwai Hospital|