Heart Failure AcuteNCT03169803
Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
A study testing NeuroTronik CANS Therapy™ System in people with Heart Failure Acute, run by NeuroTronik Inc. at 1 site in Panama.
Trial summary
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute
- What is being tested?
- NeuroTronik CANS Therapy™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePanama
- Study dates
- 19 May 2017to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left Ventricular Ejection fraction < 40%, measured in the last year
- At least two of the following:
- Pulmonary Capillary Wedge Pressure > 18 mmHg
- Pulmonary congestion on Chest X-ray
- Jugular vein distension
- Pulmonary rales
Show all 10Show fewer
- Edema
- Dyspnea at rest
- Two (2) emergency room visits or hospital admissions in the past three (3) months, or three (3) emergency room visits or admissions in the past six (6) months requiring intravenous diuretics, ultrafiltration or in-hospital inotropic therapy.
- With or without evidence of low perfusion
Who cannot join
- Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- Catecholamine or inotropic therapy within the previous 48 hours
- Levosimendan within the previous 72 hours
- Chronic outpatient catecholamine or inotropic therapy
- Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
- Presence of or prior vagal nerve stimulator
Show all 20Show fewer
- Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month
- Second or third degree heart block
- History of atrial or ventricular arrhythmias
- History of mitral or aortic valve stenosis or regurgitation
- Hypertrophic obstructive or infiltrative cardiomyopathy
- Prior vagotomy
- Prior heart transplant
- Narrow angle glaucoma
- Renal failure - either on dialysis or serum creatinine > 2.0 mg/dl
- Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase > four times upper limit of normal
- Life expectancy < 12 months per physician judgment
- Women who are pregnant
- Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
- Subjects unwilling or unable to provide consent
Trial locations and contacts
1 site in 1 country.
Panama1 site, 1 recruiting
- Recruiting
Hospital Punta Pacífica
Panama City
Temístocles Díaz, MD, +507.204.8354, hemcicompany@gmail.com
Elsa Abruzzo, +1.513.236.0857, elsa.abruzzo@neurotronikinc.com
About this study
Official title: Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
Read the detailed description
A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.
- Conditions
- Heart Failure Acute
- Being tested
- NeuroTronik CANS Therapy™ System
- Keywords
- Electrical Stimulation Therapy, Electrodes, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroTronik CANS Therapy™ SystemDevice
The NeuroTronik CANS Therapy™ System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.
| Study group | Role | What they receive |
|---|---|---|
| Single arm, NeuroTronik CANS Therapy System | Experimental | Not described Receives: Device: NeuroTronik CANS Therapy™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure
Measured: 24 hours
Heart Rate
Measured: 24 hours
Secondary outcomes (2)
Cardiac output
Measured: 24 hours
Pulmonary capillary wedge pressure
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start19 May 2017
- Primary completion19 May 2019 (estimated)
- Study completion19 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroTronik Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Temístocles Díaz, MD, Principal investigator, Hospital Punta Pacífica, Panama City, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169803
- Sponsor's protocol ID
- 700022-01
- Status last verified
- Aug 2018
- First submitted
- 25 May 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study
- ClinicalTrials.gov ID
- NCT03169803
- Acronym / sponsor ID
- 700022-01
- Conditions
- Heart Failure Acute
- Keywords
- Electrical Stimulation Therapy, Electrodes, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NeuroTronik Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 19 May 2019 (estimated)
- Study completion
- 19 Jun 2019 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
Detailed description
A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, NeuroTronik CANS Therapy System | Experimental | Device: NeuroTronik CANS Therapy™ System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Left Ventricular Ejection fraction < 40%, measured in the last year
- At least two of the following:
- With or without evidence of low perfusion
Key exclusion criteria (20 listed)
- Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- Catecholamine or inotropic therapy within the previous 48 hours
- Levosimendan within the previous 72 hours
- Chronic outpatient catecholamine or inotropic therapy
- Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroTronik CANS Therapy™ SystemThe NeuroTronik CANS Therapy™ System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable. | Device | Single arm, NeuroTronik CANS Therapy System |
Primary outcome
Arterial blood pressure
Time frame: 24 hours
Heart Rate
Time frame: 24 hours
2 secondary outcomes
Cardiac output
Time frame: 24 hours
Pulmonary capillary wedge pressure
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Temístocles Díaz, MD principal investigator
Hospital Punta Pacífica, Panama City, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroTronik CANS Therapy™ System in people with Heart Failure Acute, run by NeuroTronik Inc. at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Temístocles Díaz, MD (+507.204.8354, hemcicompany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood pressure (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.