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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04814134
Other study ID # CLN-1051-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 12, 2021
Est. completion date February 13, 2024

Study information

Verified date February 2024
Source Cardionomic Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator. Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date February 13, 2024
Est. primary completion date September 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Other:
Standard of care
Available standard treatment

Locations

Country Name City State
Belgium OLV Ziekenhuis Aalst
Belgium AZ Sint-Jan Brugge Bruges
Belgium Antwerp University Hospital Edegem
Netherlands University Medical Center Groningen Groningen
Netherlands St. Antonius Ziekenhuis Nieuwegein
Panama Punta Pacifica Panama City
United States Summa Health Akron Ohio
United States The Christ Hospital Cincinnati Ohio
United States University Hospitals Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Medical City Fort Worth Fort Worth Texas
United States Baylor College of Medicine Houston Texas
United States St. Vincent Hospital Indianapolis Indiana
United States TriStar Centennial Medical Center Nashville Tennessee
United States Oklahoma Heart Hospital South Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Cardionomic Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Measures The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths 6 months
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