Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-01 @ 1:42 AM
Study NCT ID:
NCT07224906
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2025-11-03', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between device measurements and Pulmonary Capillary Wedge Pressure', 'timeFrame': 'Day 1', 'description': 'The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Congestive Heart Failure(CHF)', 'Valve Disease, Heart']}, 'descriptionModule': {'briefSummary': 'The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects above the age of 18 who meet all inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.\n* Subjects can be any gender but must be age 18 or older.\n* Subject is able and willing to provide informed consent and HIPAA authorization.\n* Subject is able and willing to meet all study requirements.\n* Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible)\n\nExclusion Criteria:\n\n* Subject is pregnant, breastfeeding, or intends to become pregnant during this study.'}, 'identificationModule': {'nctId': 'NCT07224906', 'briefTitle': 'Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemoCept Inc.'}, 'officialTitle': 'Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart', 'orgStudyIdInfo': {'id': 'PRT-020'}}, 'contactsLocationsModule': {'locations': [{'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katharine Adkins', 'role': 'CONTACT', 'email': 'kathari.adkins@bch.org', 'phone': '303-442-2395'}, {'name': 'Scott Blois, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Boulder Heart', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'centralContacts': [{'name': 'Katharine Adkins', 'role': 'CONTACT', 'email': 'kathari.adkins@bch.org', 'phone': '303-442-2395'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemoCept Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}