Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects
COAST-HF FX
1 other identifier
interventional
30
1 country
1
Brief Summary
A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedStudy Start
First participant enrolled
June 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 23, 2018
August 1, 2018
12 months
May 18, 2018
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular pressure and volume
One hour
Secondary Outcomes (1)
Heart rate
One hour
Study Arms (1)
NeuroTronik CANS Therapy® System
EXPERIMENTALInterventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeuroTronik Inc.lead
Study Sites (1)
Sanatorio Italiano
Asunción, Paraguay
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2018
First Posted
May 31, 2018
Study Start
June 5, 2018
Primary Completion
June 1, 2019
Study Completion
July 1, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08