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Completed

NCT Number: NCT00273182

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

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Key information

Conditions

Heart Failure Cardiomyopathies Cardiomyopathy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InSync Model 8040

Device

Subjects with sucessful implants of InSync Model 8040.

InSync III Model 8042

Device

Subjects with successful implants of InSync III Model 8042

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Jan 9, 2006
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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