Clinical trial NCT00402246: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Official title: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Tachycardia
Atrial Fibrillation
Ventricular Fibrillation
Keywords: Randomized Controlled Trials
Defibrillators
Remote Consultation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Symbios Clinical
First posted: 2006-11-22
Enrollment: 2009
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility 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).

Primary outcomes:
measure: Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues
timeFrame: Enrollment to last visit (up to 15 month post-implant)
Secondary outcomes:
measure: Health Care Utilization (HCU)
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: Health Care Utilization: TEEs
timeFrame: Enrollment to last visit (up to 15 months post-implant)
measure: Actions Taken for HCU Visits
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: Clinically Meaningful Alerts
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: Symptomatic AT/AF Alerts
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: AT/AF Alert Treatment
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: Time Per Patient From a Clinical Event Onset to a Clinical Decision for Symptom-driven Device Interrogations
timeFrame: Enrollment to last visit (up to 15 month post-implant)
measure: Time Per Patient From a Clinical Event Onset to a Clinical Decision for Both Device Events and Symptom-driven Device Interrogations
timeFrame: From event onset to clinical decision
measure: CareLink Transmission Compliance
timeFrame: 3, 6, 9, 12 months visits
measure: Variability in Left Ventricular (LV) Threshold as Measured by Left Ventricular Capture Management (LVCM)
timeFrame: 1, 3, 6, 9, 12, and 15 months visits
measure: State-Anxiety Scale
timeFrame: 1, 3, 6, 9, 12, and 15 month visit
measure: Trait-Anxiety Scale
timeFrame: 1, 3, 6, 9, 12, and 15 months visits
measure: Clinic Personnel Satisfaction With Wireless Telemetry (Telemetry + Leadless ECG).
timeFrame: After study enrollment has been completed; on average 15.8 months after the center had enrolled its first subject
measure: In-office Follow-up Burden: Distance Traveled
timeFrame: 1 month visit
measure: In-office Follow-up Burden: Patient Expenses
timeFrame: 1 month
measure: In-office Follow-up Burden: Hours Absent From Work Due to Visit
timeFrame: 1 month
Other outcomes:
measure: Length of Hospital Stay (LOS)
timeFrame: Enrollment to last visit (up to 15 month post-implant)
Locations:
city: Mobile
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fort Smith
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: East Palo Alto
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Aurora
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kankakee
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Bloomington
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Ames
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Ashland
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Lanham
country: United States
state: Maryland
city: Randallstown
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Chelmsford
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Grand Blanc
country: United States
state: Michigan
city: Petoskey
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Saint Joseph
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
city: St. Cloud
country: United States
state: Minnesota
city: Hattiesburg
country: United States
state: Mississippi
city: Columbia
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Kearney
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Manchester
country: United States
state: New Hampshire
city: Cherry Hill
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: Wayne
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Fairview Park
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Mayfield Heights
country: United States
state: Ohio
city: Whitehall
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wormleysburg
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Florence
country: United States
state: South Carolina
city: Greenwood
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Woodlands
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Fredericksburg
country: United States
state: Virginia
city: Lynchburg
country: United States
state: Virginia
city: Portsmouth
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Mid-State Cardiology
name: George Crossley, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. 2011 Mar 8;57(10):1181-9. doi: 10.1016/j.jacc.2010.12.012. Epub 2011 Jan 20.
citation: 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. doi: 10.1016/j.ahj.2008.06.028. Epub 2008 Sep 11.