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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273182
• Other study ID #: 187
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: July 1, 2013
• Start date: March 2002
• Est. completion date: April 2011

Study information

• Verified date: July 2013
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical 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. 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1999
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

Intervention

Device:
• InSync Model 8040
Subjects with sucessful implants of InSync Model 8040.
• InSync III Model 8042
Subjects with successful implants of InSync III Model 8042

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 month follow-up	No
Secondary	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.	36 month follow-up	No
Secondary	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.	36 months follow-up	No
Secondary	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	36 months follow-up	No
Secondary	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.	36 months follow-up	Yes