Cardiac Output, LowCOAST-HF HNrCSNCT02880683
Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study
A study testing NeuroTronik CANS Therapy System in people with Cardiac Output, Low, run by NeuroTronik Inc. at 1 site in Paraguay.
Trial summary
A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cardiac Output, Low
- 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
- 16 participants
- Where
- 1 siteParaguay
- Study dates
- Oct 2015to Sep 2016
- 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
- Stable symptomatic heart failure - New York Heart Association Class II or III
- Normal Sinus Rhythm
Who cannot join
- Unable to gain arterial or venous access using standard percutaneous techniques
- New York Heart Association Class IV
- Patient taking amiodarone or other anti-arrhythmic therapy
- Patients with implanted pacemaker, ICD, or CRT device
- Patients who had CABG, PCI or enzyme-positive MI within prior month
- Patients with pre-existing carotid artery or cerebral disease
Show all 15Show fewer
- Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- Patients who have been hospitalized for heart failure and who required the use of heart failure IV therapy within 30 days before enrollment (measured from release)
- Patients with current or prior vagal nerve simulator
- Patients with renal failure
- Patients with hepatic failure
- Patients with narrow angle glaucoma
- Patients who are pregnant
- Patients with a life expectancy < 12 months per physician judgment
- Patients with allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
Trial locations and contacts
1 site in 1 country.
About this study
A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.
Read the detailed description
A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed.
- Conditions
- Cardiac Output, Low
- Being tested
- NeuroTronik CANS Therapy System
- Keywords
- Electrical Stimulation Therapy, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure
- Medical subject headings
- Cardiac Output, Low, 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
| Study group | Role | What they receive |
|---|---|---|
| Single arm, transvenous cardiac autonomic nerve stimulation | 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.
Cardiac output
Measured: One hour
Secondary outcomes (3)
Arterial blood pressure
Measured: One hour
Left ventricular pressure
Measured: One hour
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 posted26 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroTronik Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, Medical Doctor, Principal investigator, Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880683
- Sponsor's protocol ID
- 700019-01
- Acronym
- COAST-HF HNrCS
- Status last verified
- Oct 2016
- First submitted
- 10 Aug 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study
- ClinicalTrials.gov ID
- NCT02880683
- Acronym / sponsor ID
- COAST-HF HNrCS / 700019-01
- Conditions
- Cardiac Output, Low
- Keywords
- Electrical Stimulation Therapy, Parasympathetic Nervous System, Sympathetic Fibers, Post Ganglionic, Congestive Heart Failure, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeuroTronik Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.
Detailed description
A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, transvenous cardiac autonomic nerve stimulation | 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 (2 listed)
- Stable symptomatic heart failure - New York Heart Association Class II or III
- Normal Sinus Rhythm
Key exclusion criteria (15 listed)
- Unable to gain arterial or venous access using standard percutaneous techniques
- New York Heart Association Class IV
- Patient taking amiodarone or other anti-arrhythmic therapy
- Patients with implanted pacemaker, ICD, or CRT device
- Patients who had CABG, PCI or enzyme-positive MI within prior month
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 System | Device | Single arm, transvenous cardiac autonomic nerve stimulation |
Primary outcome
Cardiac output
Time frame: One hour
3 secondary outcomes
Arterial blood pressure
Time frame: One hour
Left ventricular pressure
Time frame: One hour
Heart rate
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- 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.
Adrian Ebner, Medical Doctor principal investigator
Facultad de Ciencias Medicas UNA Paraguay, Asuncion, Paraguay
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 Cardiac Output, Low, 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 2 inclusion and 15 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: finished, as of the sponsor's last update on 13 Oct 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (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 13 Oct 2016.