Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)
NCT ID: NCT02026635
Last Updated: 2015-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2013-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Optivol® Device in CareLink
A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admission for worsening of HF
* Discharged to home
* Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
* Enrolled in Carelink® system and able to transmit data
* Able to participate for at least 3 months
Exclusion Criteria
* End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
* Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2)
* Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
* Severe pulmonary hypertension not due to left-sided HF
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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David J Whellan, MD MHS
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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13P.296
Identifier Type: -
Identifier Source: org_study_id
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