INSIGHTS ICD Registry

December 26, 2007 updated by: Medtronic Cardiac Rhythm and Heart Failure

Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment

1326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Fountain Valley, California, United States
      • Poway, California, United States
      • Sacramento, California, United States
      • Santa Ana, California, United States
    • Colorado
      • Boulder, Colorado, United States
    • Florida
      • Bradenton, Florida, United States
      • Lakeland, Florida, United States
      • Lauderdale Lakes, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • Panama City, Florida, United States
      • Pembroke Pines, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Gainesville, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Crown Point, Indiana, United States
      • Noblesville, Indiana, United States
    • Louisiana
      • Monroe, Louisiana, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Glen Burnie, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
    • Missouri
      • Columbia, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Newark, New Jersey, United States
      • Pomona, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Mineola, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
    • North Dakota
      • Minot, North Dakota, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Kettering, Ohio, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • Texas
      • Austin, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • McAllen, Texas, United States
    • Virginia
      • Fredericksburg, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Alfred Buxton, MD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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