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

This study is ongoing, but not recruiting participants.

First Received: November 17, 2006 Last Updated: April 9, 2009 History of Changes

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic Symbios Clinical
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00402246

Purpose

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
Arrhythmia Tachycardia Atrial Fibrillation Ventricular Fibrillation	Other: Remote Management Other: In-Office Care

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

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

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

To demonstrate that the remote management system reduces the time to clinical decision for arrhythmias, cardiovascular disease progression, and system issues compared to subjects receiving only in-office care. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the impact of remote management on healthcare utilization (hospitalizations, Emergency Room (ER) visits, office visits) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

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	Other: Remote Management CareLink + Connexus + CareAlerts
2 In-Office Care	Other: In-Office Care Routine in-office care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient will be implanted with a Medtronic Conexus-enabled Cardiac Resynchronization Therapy Defibrillator (CRT-D) or Implantable Cardioverter-Defibrillator (DR-ICD) device.

Exclusion Criteria:

Patient has permanent rapid beats in the upper chamber of the heart (Atrial Fibrillation) - (constant atrial fibrillation in which pharmacological therapy or cardioversion failed or not attempted).
Patient plans to be on chronic warfarin therapy post-implant and is no longer receiving therapies to attempt to control the rhythm of the beats in their atrium.
Patient has a previous ICD, CRT-D, Implantable Pulse Generator (IPG) or Cardiac Resynchronization Therapy Pacemaker (CRT-P).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402246

Show 127 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Symbios Clinical

Investigators

Principal Investigator:

George Crossley, M.D.

Mid-State Cardiology

More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Crossley G, Boyle A, Vitense H, Sherfesee L, Mead RH. Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: the Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study. Am Heart J. 2008 Nov;156(5):840-6. Epub 2008 Sep 11.

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

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Randomized Controlled Trials
Defibrillators
Remote Consultation

Study placed in the following topic categories:

Paroxysmal Ventricular Fibrillation
Heart Diseases
Tachycardia

Atrial Fibrillation
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Atrial Fibrillation
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009