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Cardionomic STOP-ADHF Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814134
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Cardionomic Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Device: CPNS Therapy Other: Standard of care Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be enrolled in CPNS treatment arm or to the control arm. Treatment with CPNS system includes endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. Subjects in the control arm will receive the available standard treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CPNS Therapy
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Device: CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Other: Standard of care
Available standard treatment

Standard of Care
Available standard treatment
Other: Standard of care
Available standard treatment




Primary Outcome Measures :
  1. Safety Measures [ Time Frame: 6 months ]
    The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814134


Contacts
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Contact: Michelle Kennefick 6516331388 clinical@cardionomicinc.com

Locations
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United States, Indiana
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46260
United States, Ohio
Summa Health Recruiting
Akron, Ohio, United States, 44309
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Heart Hospital South Recruiting
Oklahoma City, Oklahoma, United States, 73135
United States, Tennessee
TriStar Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Medical City Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Belgium
OLV Ziekenhuis Recruiting
Aalst, Belgium
AZ Sint-Jan Brugge Recruiting
Bruges, Belgium
Antwerp University Hospital Recruiting
Edegem, Belgium
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands, 3435CM
Panama
Punta Pacifica Active, not recruiting
Panama City, Panama
Sponsors and Collaborators
Cardionomic Inc.
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Responsible Party: Cardionomic Inc.
ClinicalTrials.gov Identifier: NCT04814134    
Other Study ID Numbers: CLN-1051-001
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Cardionomic Inc.:
Neurostimulation
Contractility
Right Pulmonary Artery
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases