InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

October 3, 2007 updated by: Medtronic Cardiac Rhythm and Heart Failure

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.

The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

600

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • San Diego, California, United States
      • Stanford, California, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Palm Beach Gardens, Florida, United States
      • St. Petersburg, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Lawn, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
      • Des Moines, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • Houma, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Burlington, Massachusetts, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Cherry Hill, New Jersey, United States
      • Hackensack, New Jersey, United States
    • New York
      • Albany, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Mayfield Heights, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, 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 implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)

Exclusion Criteria:

  • Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync ICD Registry

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.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: InSync ICD Registry Study Leader, Medtronic

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

January 1, 2003

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

October 5, 2007

Last Update Submitted That Met QC Criteria

October 3, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 196

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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