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Heart FailureNCT00273182

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

An observational study of Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 82 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiomyopathy
What is being tested?
InSync Model 8040 and InSync III Model 8042
Type of treatment
Medical device
How many people
1,999 participants
Where
82 sitesUnited States
Study dates
Mar 2002to Apr 2011
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients indicated for use of a cardiac device

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

United States82 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Billings, Montana

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, Missouri

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Des Moines, Iowa

  • Study site

    Detroit, Michigan

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Duluth, Minnesota

  • Study site

    Erie, Pennsylvania

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Worth, Texas

  • Study site

    Gainesville, Florida

  • Study site

    Greenville, South Carolina

  • Study site

    Hattiesburg, Mississippi

  • Study site

    High Pointe, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jupiter, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lansing, Michigan

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lubbock, Texas

  • Study site

    Manhasset, New York

  • Study site

    Marquette, Michigan

  • Study site

    Mayfield Heights, Ohio

  • Study site

    Melbourne, Florida

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Morgantown, West Virginia

  • Study site

    Napa, California

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orlando, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Oxnard, California

  • Study site

    Peoria, Arizona

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Joseph, Missouri

  • Study site

    Salisbury, Maryland

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    Sherman, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    Silver Spring, Maryland

  • Study site

    Spartanburg, South Carolina

  • Study site

    Springfield, Illinois

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Tupelo, Mississippi

  • Study site

    Virginia Beach, Virginia

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worchester, Massachusetts

  • Study site

    York, Pennsylvania

  • Study site

    Yuba City, California

Other trials in United States

About this study

Official title: 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).

Read the detailed description

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

Being tested
InSync Model 8040, InSync III Model 8042
Keywords
Heart Failure, Cardiomyopathy, Cardiac pacing, Cardiac resynchronization therapy
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InSync Model 8040Device

    Subjects with sucessful implants of InSync Model 8040.

  • InSync III Model 8042Device

    Subjects with successful implants of InSync III Model 8042

Study groups in NCT00273182
Study groupRoleWhat they receive
CohortPatients 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.
Receives: Device: InSync Model 8040; Device: InSync III Model 8042

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.

    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

    Measured: 36 month follow-up

Secondary outcomes (4)

  1. Left Ventricular (LV) Lead R-wave Amplitude

    Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.

    Measured: 36 month follow-up

  2. Left Ventricular (LV) Lead Impedance

    Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.

    Measured: 36 months follow-up

  3. Left Ventricular (LV) Lead Pacing Voltage Threshold

    Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up

    Measured: 36 months follow-up

  4. Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant

    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.

    Measured: 36 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startMar 2002
  3. Primary completionApr 2011
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273182
Sponsor's protocol ID
187
Status last verified
Jul 2013
First submitted
4 Jan 2006
Last updated
5 Aug 2013
Data monitoring committee
No

Publications

  • Johnson WB, Abraham WT, Young JB, Wheelan K, Smith AL, Chang Y, Brinkman P; InSync Registry Investigators. Long-term performance of the attain model 4193 left ventricular lead. Pacing Clin Electrophysiol. 2009 Sep;32(9):1111-6. doi: 10.1111/j.1540-8159.2009.02451.x.

    PubMed 19719485

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 82 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. (time frame: 36 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00273182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.

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Clinical Trial NCT00273182 | AzTrials