CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,009 enrolled
Drug / intervention
Remote Management +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00402246
NCT00402246N/ACompleted

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

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Nov 22, 2006·Updated Feb 25, 2011

In Brief

A clinical study evaluating Remote Management and In-Office Care for Arrhythmia and 3 related conditions. Completed, enrolled 2,009 participants across 127 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSymbios Clinical

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartNov 1, 2006
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.6 years ago

Interventions

Remote Managementother

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.

In-Office Careother

Routine in-office care