Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT04338503
Status:
UNKNOWN
Last Update Posted:
2023-03-30
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanically Optimizing Cardiac Preload in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2020-04-05', 'studyFirstSubmitQcDate': '2020-04-05', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pulmonary arterial pressures', 'timeFrame': 'During partial balloon occlusion', 'description': 'Change in the measured mean pulmonary arterial pressure'}], 'secondaryOutcomes': [{'measure': 'Change in cardiac output', 'timeFrame': 'During partial balloon occlusion', 'description': 'Change in cardiac output measured in liters per minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary edema, preload'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Decompensated congestive heart failure patients referred for right heart catheterization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.\n2. New York Heart Association (NYHA) II or III.\n3. Subjects must be last least 18 years of age.\n4. A left ventricular ejection fraction \\>= 20%.\n5. Pulmonary artery occlusion pressure, or pulmonary wedge pressure \\>20 mmHg.\n\nExclusion Criteria:\n\n1. Subjects without sinus rhythm.\n2. Evidence of right heart failure.\n3. Patients with primary pulmonary hypertension\n4. Pulmonary wedge pressure \\<15mmHg.\n5. Significant lung disease, such as prior diagnosis of COPD.\n6. Resting or dynamic outflow tract gradient\n7. Patients with left bundle branch block'}, 'identificationModule': {'nctId': 'NCT04338503', 'briefTitle': 'Mechanically Optimizing Cardiac Preload in Heart Failure Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardioflow Technologies, LLC'}, 'officialTitle': 'Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'CFT-37215-STH-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HF patients', 'description': 'Decompensated heart failure patients undergoing right heart catheterization.', 'interventionNames': ['Diagnostic Test: Partial IVC occlusion']}], 'interventions': [{'name': 'Partial IVC occlusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Partial balloon occlusion of the inferior vena cava.', 'armGroupLabels': ['HF patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lynn Peterson', 'role': 'CONTACT', 'email': 'speterso@ascension.org', 'phone': '615-222-4504'}], 'facility': 'Saint Thomas Heart', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Daniel W Kaiser, MD', 'role': 'CONTACT', 'email': 'dan@cardioflowtech.com', 'phone': '6154152586'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardioflow Technologies, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Saint Thomas Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}