SAHZU President, academician of Chinese Academy of Science and cardiologist, Prof. WANG Jian'an and his team has successfully performed the first clinical trial implant of a novel heart failure device that integrates treatment with long-term monitoring last week at the Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China.  

The procedure marks the initiation of the HARMONY Trial, a pre-market randomized controlled trial for the NOVAtria™ system. This is the first implantable heart failure device globally to enter the RCT stage that combines therapeutic function with continuous diagnostic monitoring.

How the Device Works

The NOVAtria™ system is designed to be implanted in the atrial septum. It features a shunt intended to relieve pressure, while also incorporating a sensor that allows physicians to remotely monitor left atrial pressure. This dual capability enables post-procedure assessment of treatment efficacy and ongoing home-based monitoring, potentially allowing clinicians to detect signs of heart failure deterioration before symptoms appear.

First Patient Implant

The first recipient was a 61-year-old male with a three-year history of recurrent chest tightness and shortness of breath due to chronic heart failure. He had multiple previous hospitalizations and a pre-operative left ventricular ejection fraction of 36.9%.

Following the implant, the device's position was confirmed, and real-time left atrial pressure readings were found to correlate closely with measurements taken via right heart catheterization. The patient recovered well after the implantation, with significant improvement in symptoms.

Significance of the Development

Prof. WANG noted that the approach represents a conceptual shift in heart failure management. By combining a therapeutic intervention with continuous data collection, the system moves from episodic treatment toward a model of active, long-term disease management.

The device was developed by a domestic medical technology company. The ongoing clinical trial will further evaluate its safety and efficacy in patients with chronic heart failure.