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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00273182
First received: January 4, 2006
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
Heart Failure
Cardiomyopathy
Device: InSync Model 8040
Device: InSync III Model 8042

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. [ Time Frame: 36 month follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Left Ventricular (LV) Lead R-wave Amplitude [ Time Frame: 36 month follow-up ] [ Designated as safety issue: No ]
    Summary statistics such as mean and 95% CI for the LV lead R-wave amplitude during the 36 months of follow-up.

  • Left Ventricular (LV) Lead Impedance [ Time Frame: 36 months follow-up ] [ Designated as safety issue: No ]
    Summary statistics such as mean and 95% CI for the LV lead impedance during the 36 months of follow-up.

  • Left Ventricular (LV) Lead Pacing Voltage Threshold [ Time Frame: 36 months follow-up ] [ Designated as safety issue: No ]
    Summary statistics such as mean and 95% CI for the LV lead pacing voltage threshold during the 36 months of follow-up

  • Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant [ Time Frame: 36 months follow-up ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 1999
Study Start Date: March 2002
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients indicated for use of a cardiac device

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273182

  Show 82 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: InSync Registry Study Leader Medtronic
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00273182     History of Changes
Other Study ID Numbers: 187
Study First Received: January 4, 2006
Results First Received: April 13, 2012
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart Failure
Cardiomyopathy
Cardiac pacing
Cardiac resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014