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The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 12, 2021
Primary Completion Date
September 24, 2023
Completion Date
February 13, 2024
Last Updated
February 28, 2024
59
ACTUAL participants
CPNS Therapy
DEVICE
Standard of care
OTHER
Lead Sponsor
Cardionomic Inc.
NCT07372040
NCT06898515
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07199088