Discussion on quality control in clinical trials of interventional valvular medical devices_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

SUN Jin ¹ , ZHANG Qi ² , ZHANG Di ¹ , REN Qian ¹ , ZHOU Lun ¹ , CUI Yanyan ¹ , NIU Jing ¹ , TIAN Xichun ¹ ,  WANG Jingwen ¹ ,  MA Zhongying ¹

1. Department of Pharmacy, The First Affiliated Hospital of Air Force Medical University, Xi’an, 710032, P. R. China;
2. Shanxi Center for Drug and Vaccine Inspection, Xi’an, 710065, P. R. China;

Corresponding author：

WANG Jingwen, Email: wangjingwen8021@163.com; MA Zhongying, Email: mazhongying7@163.com

Keywords：

Heart valve; intervention; medical device; clinical trial; quality control

DOI：

10.7507/1007-4848.202301020

Video：

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With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.

Citation： SUN Jin, ZHANG Qi, ZHANG Di, REN Qian, ZHOU Lun, CUI Yanyan, NIU Jing, TIAN Xichun, WANG Jingwen, MA Zhongying. Discussion on quality control in clinical trials of interventional valvular medical devices. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(9): 1240-1245. doi: 10.7507/1007-4848.202301020 Copy

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17.	中华医学会心血管病学分会. 经导管二尖瓣缘对缘修复术的中国专家共识. 中华心血管病杂志, 2022, 50(9): 853-863.
18.	中国医师协会超声分会超声心动图专业委员会, 中国医师协会心血管内科医师分会结构性心脏病学组. 二尖瓣经导管缘对缘修复的超声心动图操作规范中国专家共识. 中国介入心脏病学杂志, 2022, 30(10): 721-733.
19.	Hijazi ZM, Ruiz CE, Zahn E, et al. SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement, part Ⅲ: Pulmonic valve. J Am Coll Cardiol, 2015, 65(23): 2556-2563.

1. 陈茂, 李侨, 熊恬园. 心脏瓣膜病介入治疗的现状和未来. 西部医学, 2021, 33(3): 313-316.
2. 林心平, 王建安. 中国心脏瓣膜病介入治疗的现状与进展. 心电与循环, 2019, 38(5): 353-356.
3. 武云龙, 王寅, 董念国. 瓣膜介入时代的思考—外科医生视角. 中国胸心血管外科临床杂志, 2021, 28(12): 1415-1419.
4. 国家药品监督管理局. 国家药监局关于发布需进行临床试验审批的第三类医疗器械目录(2020年修订版)的通告(2020年第61号). URL:https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200918103742111.html. 2020-09-18.
5. 韩雅玲, 徐凯. 中国经导管瓣膜病介入治疗现状. 华西医学, 2020, 35(9): 1035-1038.
6. 宁小平, 陆方林. 三尖瓣疾病介入治疗的研究进展. 中国心血管病研究, 2022, 20(8): 738-744.
7. 国家药品监督管理局器械审评中心. 经导管二尖瓣治疗器械研究现状及新进展. URL: https://www.cmde.org.cn//splt/ltwz/ltwy/20220902150916166.html. 2022-09-02.
8. 国家药品监督管理局. 国家药监局综合司关于印发医疗器械临床试验检查要点及判定原则的通知(药监综械注〔2018〕45号). URL:https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20181128142501830.html. 2018-11-28.
9. 魏薪, 冯沅, 陈茂, 等. 超声心动图在经导管瓣膜病介入治疗中的应用及进展. 中华心血管病杂志, 2021, 49(5): 535-542.
10. Diani CA, Rock A, Moll P. An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices. Clin Trials, 2017, 14(6): 575-583.
11. Généreux P, Piazza N, et al. Valve academic research consortium 3: Updated endpoint definitions for aortic valve clinical research. J Am Coll Cardiol, 2021, 77(21): 2717-2746.
12. Stone GW, Vahanian AS, Adams DH, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 1: Clinical trial design principles: A consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol, 2015, 66(3): 278-307.
13. Stone GW, Vahanian AS, Adams DH, et al. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: Part 1: Clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J, 2015, 36(29): 1851-1877.
14. 国家药品监督管理局医疗器械技术审评中心. 经导管植入式人工主动脉瓣膜临床试验指导原则(2019年第8号). URL: https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20190304084804184.html. 2019-03-01.
15. 中国医师协会心血管内科医师分会结构性心脏病专业委员会. 中国经导管主动脉瓣置换术临床路径专家共识(2021版). 中国循环杂志, 2022, 37(1): 12-23.
16. 中国医师协会心血管内科医师分会结构性心脏病专业委员会. 经导管主动脉瓣置换术中国专家共识(2020更新版). 中国介入心脏病学杂志, 2020, 28(6): 301-309.
17. 中华医学会心血管病学分会. 经导管二尖瓣缘对缘修复术的中国专家共识. 中华心血管病杂志, 2022, 50(9): 853-863.
18. 中国医师协会超声分会超声心动图专业委员会, 中国医师协会心血管内科医师分会结构性心脏病学组. 二尖瓣经导管缘对缘修复的超声心动图操作规范中国专家共识. 中国介入心脏病学杂志, 2022, 30(10): 721-733.
19. Hijazi ZM, Ruiz CE, Zahn E, et al. SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement, part Ⅲ: Pulmonic valve. J Am Coll Cardiol, 2015, 65(23): 2556-2563.

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