Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-01 @ 2:12 AM
Study NCT ID:
NCT05629533
Status:
UNKNOWN
Last Update Posted:
2023-11-09
First Post:
2022-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output algorithm', 'timeFrame': '9-12 months', 'description': 'To establish a correlation between the SimpleSense and the cardiac output from the right heart catheterization.'}, {'measure': 'Algorithm for Pulmonary Artery Pressure', 'timeFrame': '9 -12 months', 'description': 'To train a model for Pulmonary Artery Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Artery Pressure data from the right heart catheterization'}, {'measure': 'Algorithm for Pulmonary Wedge Pressure', 'timeFrame': '9-12 months', 'description': 'To train a model for Pulmonary Wedge Pressure estimation based on the data acquired for SimpleSense against the Pulmonary Wedge Pressure data from the right heart catheterization'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cardiac output', 'Right heart catheterization', 'SimpleSense', 'Algorithm', 'Pulmonary Artery Pressure', 'Heart failure', 'Endomyocardial biopsy', 'Cardiogenic shock'], 'conditions': ['Right Heart Catheterization']}, 'descriptionModule': {'briefSummary': "The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.", 'detailedDescription': "Patients undergoing right heart catheterization for a clinical indication including but not limited to prognosis for advanced heart failure, during endomyocardial biopsy, candidacy for heart transplant or management of cardiogenic shock.\n\nStudy Design:\n\nThe Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.\n\nNumber of subjects and sites:\n\nThe Nanowear SimpleSense study will enroll up to 100 subjects to collect data at Westchester Medical Center. The testing will include a SimpleSense device recording and simultaneous measurement of Cardiac Output, and Pulmonary Artery Pressure by right heart catheterization.\n\nDuration of study:\n\nThe duration of the Nanowear SimpleSense study is expected to be 1 year.\n\nStudy Population:\n\nSubjects of legal age to give informed consent who are undergoing right heart catheterization for a clinical indication including but not limited to :\n\n* Prognosis of advanced heart failure\n* During endomyocardial biopsy\n* Candidacy for heart transplant\n* Management of cardiogenic shock"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of legal age to give informed consent who are\n\nUndergoing right heart catheterization for a clinical indication including but not limited to :\n\n* Prognosis of advanced heart failure\n* During endomyocardial biopsy\n* Candidacy for heart transplant\n* Management of cardiogenic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has provided informed consent\n2. Male or female over the age of 18 years\n3. The patient is undergoing right heart catheterization\n\nExclusion Criteria:\n\n1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.\n2. Subjects who are pregnant\n3. Severe aortic stenosis.'}, 'identificationModule': {'nctId': 'NCT05629533', 'briefTitle': 'The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanowear Inc.'}, 'officialTitle': 'The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization', 'orgStudyIdInfo': {'id': '14-0044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase 1', 'description': 'Subjects to undergo right heart catheterization SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.\n\nUndergoing right heart catheterization for a clinical indication including but not limited to :\n\n* Prognosis of advanced heart failure\n* During endomyocardial biopsy\n* Candidacy for heart transplant\n* Management of cardiogenic shock', 'interventionNames': ['Device: SimpleSense']}, {'label': 'Phase 2', 'description': 'Subjects to undergo right heart catheterization SimpleSense data collected from the second set of subjects and evaluate the algorithms developed to estimate cardiac output from SimpleSense data. The second set of subjects are from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.', 'interventionNames': ['Device: SimpleSense']}], 'interventions': [{'name': 'SimpleSense', 'type': 'DEVICE', 'description': 'The study is observational only. No interventions will be triggered by the SimpleSense device', 'armGroupLabels': ['Phase 1', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alan Gass, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}], 'centralContacts': [{'name': 'Venk Varadan', 'role': 'CONTACT', 'email': 'venk@nanowearinc.com', 'phone': '(718) 637-4815'}, {'name': 'Alan Gass, MD', 'role': 'CONTACT', 'email': 'alan.gass@wmchealth.org', 'phone': '(845) 368-8800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanowear Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Westchester Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}