InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

NCT ID: NCT00289302

Last Updated: 2007-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Failure Cardiomyopathy

Keywords

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Heart Failure Cardiac pacing Cardiac resynchronization therapy Implantable Cardioverter Defibrillator

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac resynchronization therapy device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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InSync ICD Registry Study Leader

Role: STUDY_CHAIR

Medtronic

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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San Diego, California, United States

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Stanford, California, United States

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New Haven, Connecticut, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Oak Lawn, Illinois, United States

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Indianapolis, Indiana, United States

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Davenport, Iowa, United States

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Des Moines, Iowa, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Houma, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Burlington, Massachusetts, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Hackensack, New Jersey, United States

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Albany, New York, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Mayfield Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Providence, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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196

Identifier Type: -

Identifier Source: org_study_id