Status:
COMPLETED
The STIM-ADHF Study
Lead Sponsor:
Cardionomic Inc.
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 stimulatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05313438
Start Date
May 10 2022
End Date
September 12 2023
Last Update
November 8 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Semmelweis University, Heart and Vascular Center
Budapest, Hungary
2
Hearth Faculty of Medicine, University of Pécs
Pécs, Hungary
3
Szegedi Tudományegyetem ÁOK
Szeged, Hungary
4
American Heart of Poland
Bielsko-Biala, Poland