NCT04814134

Cardionomic STOP-ADHF Study

The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Cardionomic Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.

Detailed description

The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF). The CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator. Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.

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
OTHER	Standard of care	Available standard treatment

Timeline

• Start date: 2021-04-12
• Primary completion: 2023-09-24
• Completion: 2024-02-13
• First posted: 2021-03-24
• Last updated: 2024-02-28

Locations

15 sites across 4 countries: United States, Belgium, Netherlands, Panama

Regulatory

• FDA-regulated device study