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The STIM-ADHF Study

C

Cardionomic

Status

Completed

Conditions

Acute Decompensated Heart Failure

Treatments

Device: CPNS Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT05313438
CLN-1108-001

Details and patient eligibility

About

The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

CPNS Therapy
Experimental group
Description:
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care.
Treatment:
Device: CPNS Therapy

Trial contacts and locations

6

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Central trial contact

Michelle Kennefick

Data sourced from clinicaltrials.gov

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