InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Systems for Cardiac Resynchronization Therapy (CRT) - InSync Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,999
- 主要终点
- Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
研究概览
简要总结
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).
详细描述
Condition of Approval study for cardiac resynchronization therapy with pacemakers, and for the Attain left ventricular leads 2187, 2188, 4193, and 4194.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant.
时间窗: 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
次要结局
- Left Ventricular (LV) Lead R-wave Amplitude(36 month follow-up)
- Left Ventricular (LV) Lead Impedance(36 months follow-up)
- Left Ventricular (LV) Lead Pacing Voltage Threshold(36 months follow-up)
- Subjects With Left Ventricular (LV) Lead Related Complications During Three Years Post-implant(36 months follow-up)