US-based Cardionomic has completed the patient enrolment in its two pilot studies, STIM-ADHF and STOP-ADHF, evaluating the cardiac pulmonary nerve stimulation (CPNS) system in patients with acute decompensated heart failure (ADHF).
STOP-ADHF is a prospective, two-arm, multi-centre study (NCT04814134) with a primary outcome measure of safety after six months, as per the ClinicalTrials.gov registry.
The STIM-ADHF multi-centre, observational study (NCT05313438) is assessing the performance and safety of the CPNS system. The primary outcome will measure the number of related adverse events from the time of enrolment to 30 days post-hospital discharge, as reported on the ClinicalTrials.gov registry.
The results from these studies will be combined, with results scheduled for publication in early 2024.
The CPNS system consists of a stimulation console and an endovascular catheter, which delivers targeted stimulation to the cardiac plexus located in the right pulmonary artery.
Cardionomic’s approach is centred around the idea that stimulating the autonomic nerves enhances a patient’s clinical condition by triggering a beneficial rebalancing of the autonomic system. The shift moves the system from a maladaptive state into a cycle that continues to improve the patient’s condition even after the completion of CPNS therapy.
Explaining this in the announcement accompanying the enrolment, Dr Sitaramesh Emani, research director for advanced heart failure trials at the Christ Hospital Health Network in Ohio, said: "By stimulating the cardiac autonomic nervous system, CPNS therapy can rebalance parasympathetic/sympathetic disruptions, which can lead to meaningful improvement in acute heart failure at a fundamental level, and perhaps have a lasting impact beyond the ADHF event."
According to a report on GlobalData’s Medical Intelligence Center, neurostimulation is a key innovation area in medical devices, with Medtronic being the biggest player in the area.
GlobalData is the parent company of Clinical Trials Arena.
Neurostimulation is applied in other medical areas. In February 2023, medical technology company LivaNova launched SenTiva DUO, an implantable pulse generator (IPG) for drug-resistant epilepsy treatment. The device stimulates the Vagus nerve to treat patients with epilepsy.
Last month, US-based ElectroCore was granted a patent for a Vagus Nerve Stimulation System to alleviate seizure symptoms.
