The STIM-ADHF Study

Acute Decompensated Heart Failure Clinical Trial

Official title:

Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313438
• Other study ID #: CLN-1108-001
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: September 12, 2023

Study information

• Verified date: November 2023
• Source: Cardionomic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Locations

Country	Name	City	State
Hungary	Semmelweis University, Heart and Vascular Center	Budapest
Hungary	Hearth Faculty of Medicine, University of Pécs	Pécs
Hungary	Szegedi Tudoma´nyegyetem A´OK	Szeged
Poland	American Heart of Poland	Bielsko Biala
Slovakia	Stredoslovenský Ústav srdcových a Cievnych Chor?b, a.s.	Banská Bystrica
Slovakia	CINRE s.r.o	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Cardionomic Inc.

Countries where clinical trial is conducted

Hungary,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of related adverse events	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	Enrolment to 30 Days post hospital discharge