The clinical trial was completed within 14 months by Professor Ma Changsheng's team from Beijing Anzhen Hospital, Capital Medical University, in collaboration with more than 10 well-known electrophysiological centers nationwide, with a total enrollment of 167 patients.

All patients enrolled in safety and efficacy clinical trials enjoy a 100% immediate success rate of surgery and a much lower occurrence of postoperative complications compared to imported and other domestic products. The cryoablation system offers innovative solutions with solid product design and clinical evidence for cardiovascular physicians worldwide, and serves as an important milestone in the R&D and manufacturing of Mednovo Group. This has laid a solid foundation for future registration and even nationwide market promotion.

Atrial fibrillation

Atrial fibrillation (AF) is a common arrhythmia in clinical practice, with over 20 million patients currently present in China. AF is characterized by rapid and disorderly contraction of the atrium, causing ventricular rate (rhythm) disorder, impaired cardiac function, and increasing the possibility of atrial wall thrombus formation, reducing the quality of life of patients, and causing complications such as heart failure, stroke, and sudden death. It is a serious challenge faced by the global cardiovascular care system.

Cryoablation is an innovative technology for AF treatment. With the transforming concept, AF catheter ablation therapy has improved, it has clinical advantages such as high safety, long-lasting isolation, low recurrence rate, simple operation, and short learning curve. With the support of a large amount of evidence-based data and guidelines, more and more international AF treatment centers are making cryoablation the first choice for paroxysmal AF.

The cryoablation system is composed of a cryoablation device, a balloon cryoablation catheter, a disposable intracardiac mapping electrode catheter, and a steerable catheter sheath. It can be used for ablation treatment of paroxysmal AF.

All patients in this clinical trial suffered from paroxysmal AF. The postoperative cardiac function and laboratory indicators of patients have improved. The core indicator (immediate success rate of surgery) shows that patients have achieved pulmonary vein electrical isolation after ablation, and secondary research endpoints such as surgical operation time, X-ray operation time, cryoablation time and frequency/pulmonary vein have shown huge clinical potential.

This project is now aiming for gathering richer clinical evidence and benefit more AF patients through further development of clinical research.