A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03941691|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Septal Defect||Device: Fully Absorbable VSD Occlusion System Device: VSD Occluder||Not Applicable|
- This is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by Shanghai shape memory alloy materials co., LTD.
- This trial will recruit about 108 subjects from 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chinese Academy of Medical Sciences, Fuwai Hospital|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||April 20, 2021|
|Estimated Study Completion Date :||April 20, 2021|
Experimental: Treatment Group
Experimental group is allocated to use novel fully degradable ventricular septal defect closure system manufactured by Shanghai shape memory alloy materials co. LTD.
Device: Fully Absorbable VSD Occlusion System
Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
Active Comparator: Control Group
Control Group is allocated to use Interposition conveying device for ventricular septal defect closure produced by Shanghai shape memory alloy material co. LTD.
Device: VSD Occluder
Under echocardiography guided treatment of VSD with commercially available occluder.
- success rate of occlusion at 6 months after the surgery [ Time Frame: 6 months after the surgery ]Successful occlusion is that when follow-up under echocardiography at 6 months after surgery, the occlusion site shows no residual shunt or only a small amount of residual shunt.
- Surgical technique success rate [ Time Frame: Immediately after surgery ]After the occluder was implanted with surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely.
- technique success rate [ Time Frame: Immediately after surgery ]After the occluder was implanted with occluder and surgical intervention transport device (test group) or occluder and intervention transport device (control group), the occluder was released safely and no occluder detachment occurred during the 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): NCT03941691
|Contact: Pan Xiangbin, MD, Ph.D||010-88396666||Xiangbin428@hotmail.com|
|Hefei high-tech cardiovascular hospital||Not yet recruiting|
|Hefei, Anhui, China|
|Contact: Fang Weiyi, MD, Ph.D 0551-65722947 email@example.com|
|Structral Heart Disease Center, Fuwai Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: Pan Xiangbin, MD, Ph.D 010-88396666 firstname.lastname@example.org|
|The Second XIANGYA Hospital Of Central South University||Not yet recruiting|
|Hunan, Changsha, China|
|Contact: Tianli Zhao, MD, Ph.D 18807489179 email@example.com|
|Children's Hospital Nanjing Medical University||Not yet recruiting|
|Nanjing, Jiangsu, China|
|Contact: Mo Xuming, MD, Ph.D 18951769006 firstname.lastname@example.org|
|Principal Investigator:||Pan Xiangbin, MD, Ph.D||Chinese Academy of Medical Science, Fuwai Hospital|