Heart Failure AcuteCOAST-HF FXNCT03542123
Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
A study testing NeuroTronik CANS Therapy® System in people with Heart Failure Acute and Heart Failure, run by NeuroTronik Inc. at 1 site in Paraguay.
Trial summary
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Heart Failure Acute, Heart Failure
- 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
- 30 participants
- Where
- 1 siteParaguay
- Study dates
- 5 Jun 2018to 1 Jul 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal sinus rhythm by ECG
- Men and women 21-75 years old
- Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.
Who cannot join
- Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- Current amiodarone therapy or any other antiarrhythmic therapy
- Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month
- Enzyme-positive MI within prior 1 month
- Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release)
- History of recent severe ventricular arrhythmias
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- Pre-existing carotid artery or cerebral disease
- Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- Patients with prior vagalotomy
- Patients with current or prior vagal nerve stimulators
- Subjects with narrow angle glaucoma
- Renal failure - on dialysis or serum creatinine > 2.0 mg/dl
- Hepatic failure - bilirubin, SGOT, or SGPT > 4X upper limit of normal
- Patients with a life expectance < 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 for the protocol
Trial locations and contacts
1 site in 1 country.
Paraguay1 site, 1 recruiting
- Recruiting
Sanatorio Italiano
Asunción
Adrian Ebner, MD, 011 595 21 202767, adrian_ebner@yahoo.com
Adrian Ebner, MD
About this study
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
- Conditions
- Heart Failure Acute, Heart Failure
- 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 |
|---|---|---|
| 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.
Left ventricular pressure and volume
Measured: One hour
Secondary outcomes (1)
Heart rate
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start5 Jun 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jul 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuroTronik Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542123
- Sponsor's protocol ID
- 700003-02
- Acronym
- COAST-HF FX
- Status last verified
- Aug 2018
- First submitted
- 18 May 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Heart Failure - Hemodynamic Effects
- ClinicalTrials.gov ID
- NCT03542123
- Acronym / sponsor ID
- COAST-HF FX / 700003-02
- Conditions
- Heart Failure Acute, Heart Failure
- 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
- 30 participants (estimated)
- Lead sponsor
- NeuroTronik Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 31 May 2018 (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 single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuroTronik CANS Therapy® System | Experimental | Device: NeuroTronik CANS Therapy® System |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal sinus rhythm by ECG
- Men and women 21-75 years old
- Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.
Key exclusion criteria (17 listed)
- Systolic Blood Pressure < 90 mmHg or > 160 mmHg
- Current amiodarone therapy or any other antiarrhythmic therapy
- Coronary artery bypass graft surgery or percutaneous coronary intervention within prior 1 month
- Enzyme-positive MI within prior 1 month
- Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment (measured from release)
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 | NeuroTronik CANS Therapy® System |
Primary outcome
Left ventricular pressure and volume
Time frame: One hour
1 secondary outcome
Heart rate
Time frame: One hour
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.
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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.
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 and Heart Failure, run by NeuroTronik Inc. at 1 site in Paraguay.
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 3 inclusion and 17 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 Paraguay. 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 Adrian Ebner, Medical Doctor (011 595 21 202767, adrian_ebner@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular pressure and volume (time frame: One hour). 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.