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INSIGHTS ICD Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279968
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : December 28, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Ventricular Fibrillation Device: ICD

Study Design

Study Type : Observational
Estimated Enrollment : 1326 participants
Time Perspective: Prospective
Official Title: Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
Study Start Date : February 2004
Estimated Study Completion Date : January 2006


Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279968


  Show 44 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Principal Investigator: Alfred Buxton, MD Rhode Island Hospital
More Information

ClinicalTrials.gov Identifier: NCT00279968     History of Changes
Other Study ID Numbers: 231
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
ICD
Registry
Ventricular tachycardia
Ventricular Fibrillation

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes