N/A Completed N=1,999

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

Heart Failure · Cardiomyopathy

Source: ClinicalTrials.gov NCT00273182 ↗

Enrolled (actual)

1,999

Serious AEs

22.5%

Results posted

Aug 2013

Primary outcomePrimary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.	450; 213	—
SECONDARY Left Ventricular (LV) Lead R-wave Amplitude	13.7; 13.3; 13.2; 13.2; 13.4; 13.6	—
SECONDARY Left Ventricular (LV) Lead Impedance	620; 625; 628; 622; 632; 633	—
SECONDARY Left Ventricular (LV) Lead Pacing Voltage Threshold	1.70; 1.65; 1.69; 1.72; 1.76; 1.76	—
SECONDARY Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant	176	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00273182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.