NCT00971776终止3 期
Voyager I: Patient Discharge Using the AB5000 Portable Driver System
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Abiomed Inc.
- 入组人数
- 9
- 主要终点
- Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission
研究概览
简要总结
The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable;
- •The subject is male or female, age 18 years or older;
- •The subject is able to ambulate unassisted;
- •The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding;
- •The subject is willing and able to read, understand and sign the study specific informed consent form;
- •The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments.
排除标准
- •The subject, pre-device implant, is qualified as a transplant candidate.
- •There is an absence of a trained companion.
- •There is an absence of a psycho-social support.
- •The subject has an inadequate home environment, such as poor access which may hinder movements.
- •The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures < 90 mmHg.
- •The subject requires respiratory assistance.
- •The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL).
- •The subject requires tube feeding.
- •The subject has any other medical condition requiring hospitalization.
结局指标
主要结局
Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission
时间窗: Pre-discharge, 30 days post-discharge, 90 days or re-admission
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
不适用
Apparatus and Method for Moving PatientsCovid19Respiratory FailureNCT04882865Nova Scotia Health Authority191
撤回
不适用
Spiration IBV® Valve System and Spiration Airway Sizing KitManagement of BPF (Bronchopleural Fistulae)NCT01872312Ohio State University
终止
不适用
Ultrasound-guided Venous Access for Pacemaker and Defibrillator ImplantsAV BlockCardiac ArrhythmiaHeart FailureNCT04867460Region Skane58
已完成
不适用
Developing a Patient Oriented Discharge Summary for Stroke InpatientsStrokeNCT03177954Sunnybrook Health Sciences Centre18
招募中
不适用
Benefit of the FLYing Transport of Patients Requiring Mobile Intensive Care UnitStress, PsychologicalEmergency Medicine, TransportCritical CareNCT04578054University Hospital, Clermont-Ferrand5,000