Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
1 other identifier
interventional
40
1 country
1
Brief Summary
A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Typical duration for not_applicable
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
Study Start
First participant enrolled
May 19, 2017
CompletedFirst Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedAugust 23, 2018
August 1, 2018
2 years
May 25, 2017
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Arterial blood pressure
24 hours
Heart Rate
24 hours
Secondary Outcomes (2)
Cardiac output
24 hours
Pulmonary capillary wedge pressure
24 hours
Study Arms (1)
Single arm, 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:
- 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
- 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
You may not qualify if:
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NeuroTronik Inc.lead
Study Sites (1)
Hospital Punta Pacífica
Panama City, Panama
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Temístocles Díaz, MD
Hospital Punta Pacífica, Panama City, Panama
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 25, 2017
First Posted
May 30, 2017
Study Start
May 19, 2017
Primary Completion
May 19, 2019
Study Completion
June 19, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08