Cardionomic STOP-ADHF Study

NCT04814134 | Completed DMC FDA Device

• 1 other identifier: CLN-1051-001
• Study Type: interventional
• Target: 59
• Locations: 4 countries
• Sites: 15

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Neurostimulation; Contractility; Right Pulmonary Artery

Outcome Measures

Primary Outcomes (1)

• Safety Measures

  The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths

  6 months

Study Arms (2)

CPNS Therapy

EXPERIMENTAL

Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Device: CPNS Therapy; Other: Standard of care

Standard of Care

OTHER

Available standard treatment

Other: Standard of care

Interventions

CPNS Therapy DEVICE

Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

CPNS Therapy

Standard of care OTHER

Available standard treatment

CPNS Therapy; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardionomic Inc.: lead

Study Sites (15)

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

Summa Health

Akron, Ohio, 44309, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital South

Oklahoma City, Oklahoma, 73135, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

OLV Ziekenhuis

Aalst, Belgium

Location

AZ Sint-Jan Brugge

Bruges, Belgium

Location

Antwerp University Hospital

Edegem, Belgium

Location

University Medical Center Groningen

Groningen, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435CM, Netherlands

Location

Punta Pacifica

Panama City, Panama

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 24, 2021
• Study Start: April 12, 2021
• Primary Completion: September 24, 2023
• Study Completion: February 13, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BE (3); PA (1); US (9); NL (2)