Apogee, Addendum to the Destination Therapy Post Approval Study (DT PAS)

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合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

October 4, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 22, 2018

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Rate of major adverse events[ Time Frame: Implant to 12 months ]

Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, stroke or death.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Apogee, Addendum to the Destination Therapy Post Approval Study (DT PAS)

正式标题 ^ICMJE

Apogee, Addendum to the Destination Therapy Post Approval Study (DT PAS)

简要概况

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The Apogee study is conducted within Medtronic's Product Surveillance Platform.

详细说明

The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.

研究类型 ^ICMJE

Observational [Patient Registry]

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational [Patient Registry]
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: HeartWare Ventricular Assist Device
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).

研究工具

: HVAD

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

100

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Subjects consented to participate in DT PAS are eligible for participation in Apogee. Exclusion Criteria: - There are no exclusion criteria unique to Apogee.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Medtronic Cardiac Rhythm and Heart Failure

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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