Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-05 @ 2:19 AM
Study NCT ID:
NCT03169803
Status:
UNKNOWN
Last Update Posted:
2018-08-23
First Post:
2017-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial blood pressure', 'timeFrame': '24 hours'}, {'measure': 'Heart Rate', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': '24 hours'}, {'measure': 'Pulmonary capillary wedge pressure', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical Stimulation Therapy', 'Electrodes', 'Parasympathetic Nervous System', 'Sympathetic Fibers', 'Post Ganglionic', 'Congestive Heart Failure', 'Heart Failure'], 'conditions': ['Heart Failure Acute']}, 'descriptionModule': {'briefSummary': 'A feasibility study to investigate the safety and performance of the NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System', 'detailedDescription': 'A single-arm, safety study intended to assess safety and system performance, and the feasibility to improve hemodynamics in patients with acute heart failure syndrome using transvenous, cardiac autonomic nerve stimulation (CANS) therapy. In addition, the effects of NeuroTronik CANS Therapy™ on the congestion of patients will be studied. The study proposes that the NeuroTronik CANS Therapy™ System be deployed during the acute heart failure syndrome hospital admission, along with existing standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Left Ventricular Ejection fraction \\< 40%, measured in the last year\n2. At least two of the following:\n\n * Pulmonary Capillary Wedge Pressure \\> 18 mmHg\n * Pulmonary congestion on Chest X-ray\n * Jugular vein distension\n * Pulmonary rales\n * Edema\n * Dyspnea at rest\n * 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.\n3. With or without evidence of low perfusion\n\nExclusion Criteria:\n\n1. Systolic Blood Pressure \\< 90 mmHg or \\> 160 mmHg\n2. Catecholamine or inotropic therapy within the previous 48 hours\n3. Levosimendan within the previous 72 hours\n4. Chronic outpatient catecholamine or inotropic therapy\n5. Presence of implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy device\n6. Presence of or prior vagal nerve stimulator\n7. Coronary artery bypass graft surgery, percutaneous coronary intervention, acute myocardial infarction, or valve replacement within prior 1 month\n8. Second or third degree heart block\n9. History of atrial or ventricular arrhythmias\n10. History of mitral or aortic valve stenosis or regurgitation\n11. Hypertrophic obstructive or infiltrative cardiomyopathy\n12. Prior vagotomy\n13. Prior heart transplant\n14. Narrow angle glaucoma\n15. Renal failure - either on dialysis or serum creatinine \\> 2.0 mg/dl\n16. Hepatic failure - bilirubin, serum glutamic oxaloacetic transaminase, or serum glutamic pyruvic transaminase \\> four times upper limit of normal\n17. Life expectancy \\< 12 months per physician judgment\n18. Women who are pregnant\n19. Allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products\n20. Subjects unwilling or unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03169803', 'briefTitle': 'Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroTronik Inc.'}, 'officialTitle': 'Cardiac Output Autonomic Stimulation Therapy for Acute Heart Failure (COAST-AHF) - System Design Study', 'orgStudyIdInfo': {'id': '700022-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm, NeuroTronik CANS Therapy System', 'interventionNames': ['Device: NeuroTronik CANS Therapy™ System']}], 'interventions': [{'name': 'NeuroTronik CANS Therapy™ System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Single arm, NeuroTronik CANS Therapy System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'contacts': [{'name': 'Temístocles Díaz, MD', 'role': 'CONTACT', 'email': 'hemcicompany@gmail.com', 'phone': '+507.204.8354'}, {'name': 'Elsa Abruzzo', 'role': 'CONTACT', 'email': 'elsa.abruzzo@neurotronikinc.com', 'phone': '+1.513.236.0857'}, {'name': 'Temístocles Díaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Punta Pacífica', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Temístocles Díaz, MD', 'role': 'CONTACT', 'email': 'hemcicompany@gmail.com', 'phone': '+507.204.8354'}, {'name': 'Elsa I Abruzzo', 'role': 'CONTACT', 'email': 'elsa.abruzzo@neurotronikinc.com', 'phone': '+1.513.236.0857'}], 'overallOfficials': [{'name': 'Temístocles Díaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Punta Pacífica, Panama City, Panama'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroTronik Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}