Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02026635
Status:
WITHDRAWN
Last Update Posted:
2015-02-06
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'No subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-04', 'studyFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions', 'timeFrame': '90 days from enrollment', 'description': 'Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.'}], 'secondaryOutcomes': [{'measure': 'Heart Failure Clinical Events', 'timeFrame': '90 days from enrollment', 'description': 'Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF.'}, {'measure': 'Assess Patient-Reported Quality of Life', 'timeFrame': '90 days from enrollment', 'description': 'Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'Optivol® cardiac device', 'Medtronic CareLink'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospital inpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Admission for worsening of HF\n* Discharged to home\n* Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment\n* Enrolled in Carelink® system and able to transmit data\n* Able to participate for at least 3 months\n\nExclusion Criteria:\n\n* Post heart transplant or actively listed\n* End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support\n* Stage IV or V chronic renal dysfunction (GFR \\<25 mol/min per 1.73 M2)\n* Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen\n* Severe pulmonary hypertension not due to left-sided HF'}, 'identificationModule': {'nctId': 'NCT02026635', 'acronym': 'CONFIRM-HF', 'briefTitle': 'Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)', 'orgStudyIdInfo': {'id': '13P.296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Optivol® Device in CareLink', 'description': 'A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David J Whellan, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}