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Cardiac Device
CPNS Device Therapy for Heart Failure
Indianapolis, IN
N/A
Waitlist Available
Research Sponsored by Cardionomic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device to help people with heart failure. The device is placed under the skin and sends electrical pulses to the heart to help it pump better.
See full description
Who is the study for?
This trial is for adults hospitalized with acute decompensated heart failure, having a certain level of BNP or NT-proBNP (heart stress markers), and reduced heart function (LVEF ≤ 50%). They should have signs of fluid overload despite diuretic treatment. It's not for those with very low kidney function, severe low blood pressure, recent high-dose inotrope use, mechanical support needs, or extreme blood pressure levels.
What is being tested?
The study tests the Cardionomic CPNS system against standard care in patients with acute decompensated heart failure. The CPNS system aims to improve cardiac response by stimulating nerves that influence heart and lung function.See study design
What are the potential side effects?
While specific side effects are not listed here, similar nerve stimulation therapies can cause discomfort at the stimulation site, changes in blood pressure or heartbeat rate, headache, throat irritation or muscle twitching.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety Measures
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Available standard treatment
Group II: CPNS TherapyExperimental Treatment2 Interventions
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPNS Therapy
2021
N/A
~80
Find a Location
Closest Location:St. Vincent Hospital· Indianapolis, IN
Who is running the clinical trial?
Cardionomic Inc.Lead Sponsor
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Heart Failure
13 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows a high level of a substance called BNP or NT-proBNP.Your heart's pumping ability is below a certain level.Your kidney function is severely reduced, with an eGFR less than 25 mL/min/1.732.You have received strong heart medication or a specific kind of heart medication within a certain time frame before joining the study.Needs a machine to help with bodily functions.You were admitted to the hospital with a main diagnosis of acute decompensated heart failure.You have signs or symptoms of too much fluid in your body, even after getting a specific medication through an IV.You have a severe heart condition that could lead to shock.Your blood pressure is too low (less than 80mmHg) or too high (more than 140mmHg).You have low blood pressure and are experiencing symptoms from it.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: CPNS Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.