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.

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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
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article

Safety and Efficacy of MA01‐100: A Prospective Multicenter Trial of China's First Domestic Implantable Cardiac Monitor

Shengmei Qin, Hongxia Li, Lichuan Ping, Su Yangang et al.
Pacing and Clinical Electrophysiology
Cardiovascular Syncope and Autonomic Disorders
article

Safety and Efficacy of MA01‐100: A Prospective Multicenter Trial of China's First Domestic Implantable Cardiac Monitor

Shengmei Qin, Hongxia Li, Lichuan Ping, Su Yangang, Yang Zheng, Yi-Xiang Wang, Junbo Ge, Ruogu Li, Zhuocong Xu, L. Xu, Xueying Chen, Wei Xu, Shaocong Wang, Jin Bai, Yang Liu, Lei Zhang, Wei Wang
article en

Abstract

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.

Pacing and Clinical Electrophysiology
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)
Openalex Percentile: Top 57%
Cardiovascular Syncope and Autonomic Disorders
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Safety and Efficacy of MA01‐100: A Prospective Multicenter Trial of China's First Domestic Implantable Cardiac Monitor — Shengmei Qin, Hongxia Li, et al. · Pacing and Clinical Electrophysiology (2026) | TGRS Research Map | TGRS