Safety and Efficacy of MA01‐100: A Prospective Multicenter Trial of China's First Domestic Implantable Cardiac Monitor
This study provides the first prospective, multicenter clinical evaluation of the safety and efficacy of an intracardiac monitor (ICM) independently developed in China. It systematically validated the device's clinical performance, thereby filling the gap in China's ICM field across the entire chain of "independent development-clinical validation-translational application." The results demonstrate that the ICM meets the requirements for clinical use, providing new support for improving the accessibility of arrhythmia diagnostic services in China and offering a reference for formulating globally cost-effective cardiac monitoring strategies.
Authors
- Shengmei Qin
- Hongxia Li (ORCID: https://orcid.org/0000-0002-1440-1345)
- Lichuan Ping
- Su Yangang
- Yang Zheng (ORCID: https://orcid.org/0000-0001-9487-6350)
- Yi-Xiang Wang (ORCID: https://orcid.org/0000-0002-4021-4228)
- Junbo Ge
- Ruogu Li
- Zhuocong Xu
- L. Xu
- Xueying Chen
- Wei Xu
- Shaocong Wang
- Jin Bai
- Yang Liu
- Lei Zhang
- Wei Wang
Institutions
- Sun Yat-sen University (CN)
- Shanghai Jiao Tong University (CN)
- Fudan University (CN)
- Soochow University (CN)
- National Clinical Research Center for Digestive Diseases (CN)
- Sun Yat-sen Memorial Hospital (CN)
- Nanjing Drum Tower Hospital (CN)
- Second Affiliated Hospital of Soochow University (CN)
- Zhongshan Hospital (CN)
- Singularity University (US)
- Taian City Central Hospital (CN)
Publication Details
- Journal
- Pacing and Clinical Electrophysiology
- Published
- 2026-02-13
- DOI
- https://doi.org/10.1111/pace.70141
- Primary Topic
- Cardiovascular Syncope and Autonomic Disorders
- Type
- article
- Field-Weighted Citation Impact
- 0.00