NCT05313438

The STIM-ADHF Study

Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Cardionomic Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.

Detailed description

The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DEVICE	CPNS Therapy	Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2022-04-06
• Last updated: 2023-11-08

Locations

6 sites across 3 countries: Hungary, Poland, Slovakia

Regulatory

• FDA-regulated device study