Status:
COMPLETED
Cardionomic STOP-ADHF Study
Lead Sponsor:
Cardionomic Inc.
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 n...
Eligibility Criteria
Inclusion
- Admitted to hospital with a principal diagnosis of ADHF
- BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
- LVEF ≤ 50%
- At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent)
Exclusion
- Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment
- Requires mechanical support
- Cardiogenic shock or impending cardiogenic shock
- Systolic blood pressure \< 80mmHg or \> 140mmHg
- Symptomatic hypotension
- eGFR \< 25 mL/min/1.732
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04814134
Start Date
April 12 2021
End Date
February 13 2024
Last Update
February 28 2024
Active Locations (15)
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1
St. Vincent Hospital
Indianapolis, Indiana, United States, 46260
2
Summa Health
Akron, Ohio, United States, 44309
3
The Christ Hospital
Cincinnati, Ohio, United States, 45219
4
University Hospitals
Cleveland, Ohio, United States, 44106