InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry

July 1, 2013 updated by: Medtronic Cardiac Rhythm and Heart Failure

InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry

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.

The purpose of this study is to monitor the long-term performance of the InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) systems for cardiac resynchronization therapy (CRT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.

Study Type

Observational

Enrollment (Actual)

1999

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
    • Arizona
      • Peoria, Arizona, United States
    • Arkansas
      • Ft. Smith, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Long Beach, California, United States
      • Napa, California, United States
      • Oxnard, California, United States
      • San Diego, California, United States
      • Yuba City, California, United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Jupiter, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Rockford, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Overland Park, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Lake Charles, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worchester, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Lansing, Michigan, United States
      • Marquette, Michigan, United States
      • Saginaw, Michigan, United States
    • Minnesota
      • Duluth, Minnesota, United States
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Hattiesburg, Mississippi, United States
      • Tupelo, Mississippi, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Springfield, Missouri, United States
      • St. Joseph, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New York
      • Manhasset, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • High Pointe, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, 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
      • Doylestown, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • York, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Greenville, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Ft. Worth, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
      • Sherman, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, 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

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for use of a cardiac device

Description

Inclusion Criteria:

  • Patients implanted with an InSync Model 8040 or InSync III Model 8042, a right ventricular lead, and a Medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy.

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Patients implanted with InSync Model 8040, InSync III Model 8042 , or Medtronic CRT-D system. A total of 1999 subjects were enrolled in the study. Of them, 1738 had successful post market implants of InSync Model 8040 (601 subjects), InSync III Model 8042 (512 subjects) and CRT-D devices (625 subjects). The rest 262 subjects came from two pre-market studies: the MIRACLE study added 141 subjects to InSync Model 8040, and the InSync III study added 121 subjects to the InSync III Model 8042. A total of 1014 subjects completed the study through 36 month follow up. Follow-up of 1000 subjects was required by the FDA to satisfy the conditions of approval.
Device: InSync Model 8040
Subjects with sucessful implants of InSync Model 8040.
Device: InSync III Model 8042
Subjects with successful implants of InSync III Model 8042

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
Time Frame: 36 month follow-up
Survival curves of overall mortality and cause specific mortality (due to progressive heart failure and sudden cardiac death) were created based on Kaplan-Meier estimates. Estimates went out to 36 month time point. Confidence intervals were calculated on a log-log scale. The Kaplan-Meier estimates are reported in the statistical analysis modules
36 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular (LV) Lead R-wave Amplitude
Time Frame: 36 month follow-up
Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.
36 month follow-up
Left Ventricular (LV) Lead Impedance
Time Frame: 36 months follow-up
Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.
36 months follow-up
Left Ventricular (LV) Lead Pacing Voltage Threshold
Time Frame: 36 months follow-up
Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up
36 months follow-up
Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant
Time Frame: 36 months follow-up

A left ventricular lead related complication is defined as an adverse event that requires invasive intervention or leads to loss of significant device function resulting from the presence or performance of the LV lead.

Kaplan-Meier method was used to estimate complication-free rate during the three years of follow-up. Time to the first post-implant LV lead related complication was used for the calculation. Confidence intervals were calculated on a log-log scale.
36 months follow-up

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 Registry Study Leader, Medtronic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2002

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

August 5, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 187

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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