Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-02-21 @ 2:07 AM
Study NCT ID:
NCT01626404
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2012-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Advanced Heart Failure Treatment (SEE-HF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients', 'timeFrame': '12 months', 'description': 'Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF \\</= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD.'}], 'secondaryOutcomes': [{'measure': 'Reasons for non-referral', 'timeFrame': '12 months', 'description': "Assess physician's reasons for non-referral of patients for LVAD/transplant evaluation."}, {'measure': "Patient's reasons", 'timeFrame': '12 months', 'description': 'Assess patients reasons for declining LVAD/transplant as a treatment option.'}, {'measure': 'Actual and predicted 12 month survival', 'timeFrame': '12 months', 'description': 'Assess the actual and predicted 12 month survival (predicted by VO2, the Heart Failure Survival Score (HFSS) and the Seattle Heart Failure Model (SHFM)).'}, {'measure': 'Simple clinical parameters for referral', 'timeFrame': '12 months', 'description': 'Identify simple clinical parameters that can be used by physicians to refer patients for LVAD/transplant evaluation at an optimal time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thoratec Corporation'], 'conditions': ['Advanced Heart Failure', 'CRT and/or ICD']}, 'descriptionModule': {'briefSummary': 'Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with CRT and/or ICD, EF \\</= 40% and in NYHA III-IV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRT and or ICD device in place.\n* NYHA class III - IV heart failure\n* EF \\</= 40%\n* Patient is an out-patient\n* Patient is on optimal medical management as tolerated and as defined by primary care physician.\n* Patient has signed an informed consent for data collection.\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>80 years\n* CRT device that has been implanted \\< 3 months prior to enrollment\n* Coronary revascularization within 3 months prior to enrollment\n* Patient only has ICD but has CRT planned\n* Non-cardiac disease resulting in life expectancy \\< 2 yrs\n* Patient is hospitalized or will be hospitalized at this time\n* Known diagnosis of dementia\n* Patient is currently on dialysis\n* Oxygen dependent lung disease\n* Previously or currently treated with LVAD or heart transplantation'}, 'identificationModule': {'nctId': 'NCT01626404', 'acronym': 'SEE-HF', 'briefTitle': 'Screening for Advanced Heart Failure Treatment (SEE-HF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Screening for Advanced Heart Failure Treatment (SEE-HF)', 'orgStudyIdInfo': {'id': 'TC-060112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients enrolled', 'description': 'All patients enrolled in the study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical Center', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'University Clinical Center Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University Hospital of South Manchester NHS Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Pooja Chatterjee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thoratec Europe Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Europe Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}