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Trial record 2 of 2 for:    cardionomic
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The STIM-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: NCT05313438
Recruitment Status : Recruiting
First Posted : April 6, 2022
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Cardionomic Inc.

Study Description
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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.

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

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 stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure
Actual Study Start Date : May 10, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: CPNS Therapy
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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of related adverse events [ Time Frame: Enrolment to 30 Days post hospital discharge ]
    The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths


Eligibility Criteria
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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 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 Criteria:

  • 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
Contacts and Locations
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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): NCT05313438


Contacts
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Contact: Michelle Kennefick 6516331388 clinical@cardionomicinc.com

Locations
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Hungary
Semmelweis University, Heart and Vascular Center Recruiting
Budapest, Hungary
Hearth Faculty of Medicine, University of Pécs Recruiting
Pécs, Hungary
Szegedi Tudományegyetem ÁOK Recruiting
Szeged, Hungary
Poland
American Heart of Poland Recruiting
Bielsko Biala, Poland
Slovakia
Stredoslovenský Ústav srdcových a Cievnych Chorȏb, a.s. Recruiting
Banská Bystrica, Slovakia, 97401
CINRE s.r.o Recruiting
Bratislava, Slovakia
Sponsors and Collaborators
Cardionomic Inc.
More Information
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Responsible Party: Cardionomic Inc.
ClinicalTrials.gov Identifier: NCT05313438    
Other Study ID Numbers: CLN-1108-001
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: September 26, 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
Product Manufactured in and Exported from the U.S.: 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