Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 6:01 AM
Study NCT ID:
NCT05866666
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Performance System Data Collection Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Performance System electronic data for Cardiac Output', 'timeFrame': '10 minutes before cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Cardiac Output to report in L/m.'}, {'measure': 'Cardiac Performance System electronic data for Pulmonary Artery Pressure', 'timeFrame': '10 minutes before cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.'}, {'measure': 'Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure', 'timeFrame': '10 minutes before cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.'}, {'measure': 'Pulmonary Artery Catheter electronic data for Cardiac Output', 'timeFrame': '60 minutes during cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Cardiac Output to report in L/m.'}, {'measure': 'Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure', 'timeFrame': '60 minutes during cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.'}, {'measure': 'Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure', 'timeFrame': '60 minutes during cardiac catheterization procedure', 'description': 'Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.'}, {'measure': 'Echocardiography electronic data for Ejection Fraction', 'timeFrame': '15 minutes at a time prior to or after Pulmonary Artery Catheter procedure', 'description': 'Cardiac function measurement including left ventricle ejection fraction to report in percentage.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': 'Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)', 'detailedDescription': 'Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for cardiac catheterization procedure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent\n* 22 years of age or older\n* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.\n\nExclusion Criteria:\n\n* Previous Heart Transplant\n* Presence of Left Ventricular Assist Device\n* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement\n* Surgical scars/wounds/bandages/ports at the site of sensor placement'}, 'identificationModule': {'nctId': 'NCT05866666', 'briefTitle': 'Cardiac Performance System Data Collection Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensydia Corporation'}, 'officialTitle': 'Cardiac Performance System Data Collection Study', 'orgStudyIdInfo': {'id': 'CPS_ORLANDO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Function Monitoring', 'description': 'Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.', 'interventionNames': ['Device: Cardiac Performance System (NSR)']}], 'interventions': [{'name': 'Cardiac Performance System (NSR)', 'type': 'DEVICE', 'description': 'Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function.', 'armGroupLabels': ['Cardiac Function Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yahaira Ortiz-Gonzalez, MD', 'role': 'CONTACT', 'phone': '321-843-9657'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'centralContacts': [{'name': 'Sensydia', 'role': 'CONTACT', 'email': 'info@sensydia.com', 'phone': '6618774670'}], 'overallOfficials': [{'name': 'Yahaira Ortiz-Gonzalez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensydia Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Orlando Health, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}