Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00334451
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2006-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RAPID-RF: Remote Active Monitoring in Patients With Heart Failure
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': 891}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-20', 'studyFirstSubmitDate': '2006-06-05', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Remote Monitoring', 'Implantable Device'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17517341', 'type': 'DERIVED', 'citation': 'Saxon LA, Boehmer JP, Neuman S, Mullin CM. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. J Card Fail. 2007 May;13(4):241-6. doi: 10.1016/j.cardfail.2006.12.004.'}]}, 'descriptionModule': {'briefSummary': "The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature: LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and alert-related medical interventions. This registry will also assess clinical outcomes including quality of life and New York Heart Association Class changes over time, mortality, hospitalizations and heart failure-related event rates."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinics, heart failure clinics, hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who meet current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy\n* Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.\n* Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor\n* Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry\n* Patients who remain in the clinical care of a RAPID-RF investigator at approved centers\n\nExclusion Criteria:\n\n* Patients who are expected to receive a heart transplant during the course of the study\n* Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study\n* Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)\n* Patients whose life expectancy is less than 12 months\n* Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.\n* Patients who are younger than 18 years of age\n* Patients who are pregnant or plan to become pregnant during the study\n* Patients who are unable or refuse to comply with the protocol requirements"}, 'identificationModule': {'nctId': 'NCT00334451', 'briefTitle': 'RAPID-RF: Remote Active Monitoring in Patients With Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Remote Active Monitoring in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'CR-CA-030206-H'}, 'secondaryIdInfos': [{'id': 'RAPID RF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Leslie A Saxon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'John P Boehmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hershey Medical Center, Hershey, PA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}