NCT00402246

CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,009 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arrhythmia
• Tachycardia
• Atrial Fibrillation
• Ventricular Fibrillation

Interventions

Type	Name	Description
OTHER	Remote Management	The Remote Management method of treating patients consists of 3 components: CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day) Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician. The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action.
OTHER	In-Office Care	Routine in-office care

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-11-22
• Last updated: 2011-02-25
• Results posted: 2011-02-16

Locations

127 sites across 1 country: United States