Safety and Efficacy of MA01-100: A Prospective Multicenter Trial of China's First Domestic Implantable Cardiac Monitor  期刊论文  

Background Unexplained syncope and palpitations are common chief complaints in the outpatient department of cardiology. Their sporadic and unpredictable poses significant diagnostic challenges. Implantable cardiac monitors (ICMs) can monitor arrhythmia events efficiently, and can overcome the shortcomings of traditional electrocardiogram (ECG) detection tools such as Holter. However, the high cost of imported ICM devices limits accessibility for patients in China. The MA01-100 (Singular Medical, Suzhou, China), the first domestically developed ICM, may offer a cost-effective alternative. This study aimed to evaluate the safety and efficacy of the MA01-100 compared with standard surface electrocardiography (ECG) for arrhythmia monitoring in Chinese patients.Methods A prospective, paired design trial was conducted across six hospitals in China. Sixty-four participants underwent implantation of the MA01-100 ICM device. As the self-control group, patients were also assessed using a surface ECG at implantation, and 30- and 90-day follow-ups. The primary efficacy endpoints were the sensitivity and positive predictive value (PPV) of R wave detection at 30 days post-implantation. Secondary endpoints included R wave amplitude stability, QRS complex morphology consistency, arrhythmia event detection rate, arrhythmia event identification accuracy, clinical performance evaluation of the programmer, and remote transmission function assessment. Safety was evaluated by the incidence rates of major adverse events (MAEs), serious adverse events (SAEs), and device defects within 3 months of follow-up.Results All 64 patients who met the inclusion criteria were enrolled in the trial. They underwent successful cardiac monitor implantation with acceptable sensitivity and PPV of R wave detection. The mean sensitivity was 99.98 +/- 0.10%, with a minimum of 99.34%. The two-sided 95% confidence interval (CI) for the compliance rate was (94.40%-100.00%). The mean PPV was 99.94 +/- 0.35%, with a minimum of 97.35%. The two-sided 95% CI for the compliance rate was (94.40%-100.00%). Two patients (3.1%) experienced mild implantation site infections; no device defects or SAEs were observed. All pre-defined efficacy and safety benchmarks were met.Conclusion 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.