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INSIGHTS ICD Registry

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00279968
First received: January 19, 2006
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  Purpose

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 Intervention
Ventricular Tachycardia
Ventricular Fibrillation
 Device: ICD

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 1326
Study Start Date: February 2004
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279968

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

No publications provided

ClinicalTrials.gov Identifier: NCT00279968     History of Changes
Other Study ID Numbers: 231
Study First Received: January 19, 2006
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
ICD
Registry
Ventricular tachycardia
Ventricular Fibrillation

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

ClinicalTrials.gov processed this record on May 23, 2013