Cardionomic STOP-ADHF Study

Cardionomic Inc.59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Decompensated Heart Failure

Interventions

CPNS TherapyDEVICE

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

Standard of careOTHER

Available standard treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

St. Vincent Hospital

Indianapolis, Indiana, United States

Summa Health

Akron, Ohio, United States

The Christ Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Safety Measures

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

Time frame: 6 months

Data from ClinicalTrials.gov

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