Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2021-04-12
2024-02-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPNS Therapy
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Standard of care
Available standard treatment
Standard of Care
Available standard treatment
Standard of care
Available standard treatment
Interventions
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CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Standard of care
Available standard treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* Requires mechanical support
* Cardiogenic shock or impending cardiogenic shock
* Systolic blood pressure \< 80mmHg or \> 140mmHg
* Symptomatic hypotension
* eGFR \< 25 mL/min/1.732
18 Years
ALL
No
Sponsors
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Cardionomic Inc.
INDUSTRY
Responsible Party
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Locations
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St. Vincent Hospital
Indianapolis, Indiana, 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
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Medical City Fort Worth
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
OLV Ziekenhuis
Aalst, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
Antwerp University Hospital
Edegem, , Belgium
University Medical Center Groningen
Groningen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Punta Pacifica
Panama City, , Panama
Countries
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Other Identifiers
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CLN-1051-001
Identifier Type: -
Identifier Source: org_study_id
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