Clinical trial NCT00279981: TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Official title: TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Heart Failure
Keywords: Atrial fibrillation
Stroke
Pacemaker
Implantable Cardiac Defibrillator
Resynchronization systems
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-20
Enrollment: 3100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this information from many patients to see if heart rate or rhythm data can predict the risk of a patient having a medical condition such as stroke.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent and privacy/protection authorization.
* Subjects 65 years of age or older.

OR

* Subjects with age \>18 and \< 65 years and one of the following stroke risk factors:
* Prior stroke or TIA
* Diagnosis of hypertension (HTN)
* Diagnosis of Diabetes Mellitus (DM)
* Diagnosis of Congestive Heart Failure (CHF)
* Subjects who meet the Class I/Class II indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device

OR

• Subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe CHF symptoms \[NYHA Class III-IV\] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a QRS duration ≥130 ms)13.

Exclusion Criteria:

* Subjects who are to receive a replacement IPG, ICD or CRT device.
* Subjects with chronic (permanent) AT/AF.
* Subjects with a history of AV nodal dependent arrhythmias.
* Subjects with a terminal illness who are not expected to survive more than 6 months.
* Subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
* Subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
* Subjects who are or will be inaccessible for follow-up at a qualified study center.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Modesto
country: United States
state: California
city: National City
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Salinas
country: United States
state: California
city: San Bernadino
country: United States
state: California
city: Torrance
country: United States
state: California
city: Norwalk
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Ft. Lauderdale,
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Munster
country: United States
state: Indiana
city: Ames
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Ashland
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Slidell
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Brighton
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Grand Blanc
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Mt. Clemens
country: United States
state: Michigan
city: Saginaw
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: St. Paul,
country: United States
state: Minnesota
city: Gulfport
country: United States
state: Mississippi
city: Hattiesburg
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Camden
country: United States
state: New Jersey
city: Cherry Hill
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Haddon Heights
country: United States
state: New Jersey
city: West Orange
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Pinehurst
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem,
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Fairview Park
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Midwest City
country: United States
state: Oklahoma
city: Easton
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin,
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Ft. Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Liverpool
country: Australia
state: New South Wales
city: New Lambton
country: Australia
state: New South Wales
city: Bedford Park
country: Australia
state: South Australia
city: Perth-Western Australia
country: Australia
city: Calgary
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
Study officials:
affiliation: Riverside Hospital
name: Emile Daoud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Taya Glotzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yano Y, Greenland P, Lloyd-Jones DM, Daoud EG, Koehler JL, Ziegler PD. Simulation of Daily Snapshot Rhythm Monitoring to Identify Atrial Fibrillation in Continuously Monitored Patients with Stroke Risk Factors. PLoS One. 2016 Feb 16;11(2):e0148914. doi: 10.1371/journal.pone.0148914. eCollection 2016.
citation: Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.