Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 8:41 AM
Study NCT ID:
NCT01366703
Status:
UNKNOWN
Last Update Posted:
2012-05-15
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Heart Failure Therapy Through Continuous Monitoring
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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-12', 'studyFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2011-06-03', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'registered arrhythmias with implantable loop recorder during follow-up period', 'timeFrame': '1 year follow-up after last included patient', 'description': "Primary study parameters/outcome of the study:\n\n* AF burden en AF episodes detected\n* Detected other relevant arrhythmia's like supraventricular tachycardia's (SVT's, not AF) or ventricular tachycardia's (VT's) or bradycardias\n* % patiënts on OAC after 1 year follow-up\n* Number of clinically relevant patient activated events\n* Number of treatment policy changes based on the Reveal XT"}], 'secondaryOutcomes': [{'measure': 'prediction of worsening heart failure through cardiac compass', 'timeFrame': 'during follow-up (1 year after last included patient)', 'description': 'Predective value of the cardiac Compass data to predict worsening heart failure episodes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart failure', 'implantable loop recorder'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': "Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care.\n\nObjective of the study:\n\nTo investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score \\>2), currently not treated with oral anticoagulation (OAC).\n\nStudy design:\n\nIn 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score\\>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC.\n\nStudy population:\n\n50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.\n\nPrimary study parameters/outcome of the study:\n\nPrimary endpoints\n\n* AF burden and AF episodes detected\n* Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias\n* % patients on OAC after 1 year follow-up\n* Number of clinically relevant patient activated events\n* Number of treatment policy changes based on the Reveal XT\n\nSecondary study parameters/outcome of the study\n\n* specificity of AF detection algorithm by the Reveal\n* Predictive value of the cardiac Compass data to predict worsening heart failure episodes.", 'detailedDescription': 'no additional description needed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 patients with stable heart failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EF \\> 35%\n* NYHA 2-3\n* No AF documented\n* Not on OAC\n\nExclusion Criteria:\n\n* use of OAC\n* documented AF \\> 30 sec\n* planned or actual PM/ICD\n* life-expectancy \\< 1 year\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01366703', 'acronym': 'pharao', 'briefTitle': 'Optimized Heart Failure Therapy Through Continuous Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Kennemer Gasthuis'}, 'officialTitle': 'Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study', 'orgStudyIdInfo': {'id': 'pharao multicentre study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'heart failure patients', 'description': 'stable heart failure patients, NYHA 1-2, EF \\> 35%, no AF, No OAC, CHADS score \\>2', 'interventionNames': ['Device: implantable loop recorder Medtronic reveal XT Full view']}], 'interventions': [{'name': 'implantable loop recorder Medtronic reveal XT Full view', 'type': 'DEVICE', 'otherNames': ['Medtronic reveal XT Full view'], 'description': 'Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up', 'armGroupLabels': ['heart failure patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arnhem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'hans bosker, MD PhD', 'role': 'CONTACT', 'email': 'hbosker@alysis.nl'}], 'facility': 'Rijnstate ziekenhuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Deventer', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ype Tuininga, MD PhD', 'role': 'CONTACT', 'email': 'y.s.tuininga@dz.nl'}], 'facility': 'Deventer Ziekenhuis', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'city': 'Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Robert Tieleman, MD PhD', 'role': 'CONTACT', 'email': 'r.tieleman@mzh.nl'}], 'facility': 'Martini Ziekenhuis', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2000 AK', 'city': 'Haarlem', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'raymond tukkie, MD PhD', 'role': 'CONTACT', 'email': 'tukkie@kg.nl', 'phone': '+31 23 5453545'}, {'name': 'Bob van Vlies, MD PhD', 'role': 'CONTACT', 'email': 'vlies@kg.nl', 'phone': '+31 23 5453545'}, {'name': 'raymond tukkie, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kennemer gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'city': 'Leiderdorp', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Charles Kirchhof, MD PhD', 'role': 'CONTACT', 'email': 'ch.kirchhof@orange.nl'}], 'facility': 'Rijnland Ziekenhuis', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}], 'centralContacts': [{'name': 'raymond tukkie, MD PhD', 'role': 'CONTACT', 'email': 'tukkie@kg.nl', 'phone': '+31 23 5453545'}, {'name': 'Robert Tieleman, MD PhD', 'role': 'CONTACT', 'email': 'r.tieleman@mzh.nl', 'phone': '+31 50 5245245'}], 'overallOfficials': [{'name': 'raymond tukkie, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kennemer Gasthuis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kennemer Gasthuis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. R. Tukkie MD PhD FESC', 'investigatorAffiliation': 'Kennemer Gasthuis'}}}}