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Sponsors and Collaborators: |
Medtronic Cardiac Rhythm Disease Management Medtronic Symbios Clinical |
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Information provided by: | Medtronic Cardiac Rhythm Disease Management |
ClinicalTrials.gov Identifier: | NCT00402246 |
The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.
Condition | Intervention |
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Arrhythmia Tachycardia Atrial Fibrillation Ventricular Fibrillation |
Other: Remote Management Other: In-Office Care |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision |
Enrollment: | 2009 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Remote Management
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Other: Remote Management
CareLink + Connexus + CareAlerts
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2
In-Office Care
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Other: In-Office Care
Routine in-office care
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | George Crossley, M.D. | Mid-State Cardiology |
Responsible Party: | Medtronic CRDM Clinical Research ( CRDM Core Clinical ) |
Study ID Numbers: | 605 |
Study First Received: | November 17, 2006 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00402246 History of Changes |
Health Authority: | United States: Institutional Review Board |
Randomized Controlled Trials Defibrillators Remote Consultation |
Paroxysmal Ventricular Fibrillation Heart Diseases Tachycardia |
Atrial Fibrillation Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Tachycardia Cardiovascular Diseases |
Atrial Fibrillation Ventricular Fibrillation Arrhythmias, Cardiac |