Acute decompensated heart failure (ADHF) is the sudden worsening of heart failure symptoms. Credit: Mohammed Haneefa Nizamudeen via Getty Images.

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. 

Related Company Profiles

View all

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. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.