The STIM-ADHF Study

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: CPNS Therapy

• Registration Number: NCT05313438
• Lead Sponsor: Cardionomic Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2022-05-10
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
• BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
• LVEF ≤ 50%
• At least one sign/symptom of fluid overload
• At least one of the following:
• Inadequate diuretic response
• At least one sign or symptom of low perfusion

Exclusion Criteria

• Received an inotrope during current hospitalization
• Requires mechanical support
• Cardiogenic shock or impending cardiogenic shock
• Multi-organ failure
• Systolic blood pressure < 80mmHg or > 140mmHg
• Symptomatic hypotension
• eGFR < 25 mL/min/1.732
• Severe hepatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPNS Therapy	CPNS Therapy	Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care.

Primary Outcome Measures

Name	Time	Method
Occurrence of related adverse events	Enrolment to 30 Days post hospital discharge	The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths

Trial Locations

Locations (6)

CINRE s.r.o; 🇸🇰 Bratislava, Slovakia

Stredoslovenský Ústav srdcových a Cievnych Chorȏb, a.s.; 🇸🇰 Banská Bystrica, Slovakia

Szegedi Tudományegyetem ÁOK; 🇭🇺 Szeged, Hungary

Hearth Faculty of Medicine, University of Pécs; 🇭🇺 Pécs, Hungary

American Heart of Poland; 🇵🇱 Bielsko Biala, Poland

Semmelweis University, Heart and Vascular Center; 🇭🇺 Budapest, Hungary