Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
NCT ID: NCT03542123
Last Updated: 2018-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-06-05
2019-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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NeuroTronik CANS Therapy® System
NeuroTronik CANS Therapy® System
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.
Interventions
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NeuroTronik CANS Therapy® System
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.
Eligibility Criteria
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Inclusion Criteria
* Men and women 21-75 years old
* Patients with stable symptomatic heart failure, New York Heart Association (NYHA) class II, III, or IV.
Exclusion Criteria
* 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
* 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
21 Years
75 Years
ALL
No
Sponsors
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NeuroTronik Inc.
INDUSTRY
Responsible Party
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Locations
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Sanatorio Italiano
Asunción, , Paraguay
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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700003-02
Identifier Type: -
Identifier Source: org_study_id
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