Clinical trial NCT00279968: INSIGHTS ICD Registry
Official title: Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Keywords: ICD
Registry
Ventricular tachycardia
Ventricular Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-20
Enrollment: 1326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older.
* Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.
* New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.

Exclusion Criteria:

* Patients enrolled in a device study which effects programming and or treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Poway
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Gainesville
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Crown Point
country: United States
state: Indiana
city: Noblesville
country: United States
state: Indiana
city: Monroe
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: Pomona
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Minot
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Virginia
Study officials:
affiliation: Rhode Island Hospital
name: Alfred Buxton, MD
role: PRINCIPAL_INVESTIGATOR
References: