CPNS Pilot Study: Evaluation of Safety and Performance of the Cardiac Pulmonary Nerve Stimulation (CPNS) System in Patients With ADHF

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    90
  • sponsor
    Cardionomic Inc.
Updated on 10 May 2022

Summary

The CPNS Pilot Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.

Description

The CPNS Pilot Study is a prospective, multi-center and multinational study to evaluate the safety and performance of the CPNS System in patients hospitalized 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-discharges from the hospital. Patients assigned to the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients randomized to the control arm in Phase 2 will receive standard treatment for their heart failure.

Details
Condition Acute Decompensated Heart Failure
Treatment Standard of Care, CPNS Therapy
Clinical Study IdentifierNCT04814134
SponsorCardionomic Inc.
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Admitted to hospital with a principal diagnosis of ADHF
BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
LVEF ≤ 45%
At least one sign/symptom of fluid overload
At least one of the following
inadequate diuretic response
least one sign or symptom of low perfusion

Exclusion Criteria

First IV treatment upon presentation in hospital to randomization > 48 hours
Received an inotrope or anticipated to receive an inotrope in the 12 hours following enrollment
Requires mechanical support or anticipated to receive mechanical support in the 12 hours following enrollment
Systolic blood pressure < 80mmHg or > 130mmHg
Symptomatic hypotension
eGFR < 25 mL/min/1.732
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

0/250

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