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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05313438
Other study ID # CLN-1108-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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