Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure

  • STATUS
    Recruiting
  • End date
    May 13, 2023
  • participants needed
    50
  • sponsor
    Cardionomic Inc.
Updated on 13 October 2022

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.

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.

Details
Condition Acute Decompensated Heart Failure
Treatment CPNS Therapy
Clinical Study IdentifierNCT05313438
SponsorCardionomic Inc.
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note