NCT01977014已完成不适用
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
NordicInfu Care AB8 个研究点 分布在 3 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Number and severity of events reported for the Lenus Pro in a clinical environment.
研究概览
简要总结
This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment.
Participating centres are located in Denmark, Norway and Sweden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient should have been diagnosed with Pulmonary Arterial Hypertension
- •The patient has received or will receive treatment with the implanted pump LenusPro
排除标准
- •The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice
结局指标
主要结局
Number and severity of events reported for the Lenus Pro in a clinical environment.
时间窗: Up to 3,5 years
Changes in baseline variables during follow-up on quality of life.
时间窗: Up to 3,5 years
Patient reported outcome measures, mainly CAMPHOR and SF-36
次要结局
- Description of baseline and follow-up of hemodynamic and functional capacity.(Up to 3,5 years)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertensioChronic obstructive pulmonary disease (COPD) with secondary pulmonary hypertensionRespiratoryOther chronic obstructive pulmonary diseaseISRCTN61661881niversity Hospital Basel (Switzerland)17
Unknown
不适用
Imaging Control Study, 3D Echo, MR and RHC.Pulmonary Arterial Hypertension WHO Group INCT02198456Regina Steringer-Mascherbauer12
已完成
不适用
NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single InhalerAsthmaNCT00557297AstraZeneca250
已完成
不适用
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)Heart FailureNCT00893828Boston Scientific Corporation18
撤回
2 期
A Phase II Trial of Proton Pump Inhibitors With Chemotherapy in Patients With Metastatic Head and Neck CancerCancer of Head and NeckNCT02013453University of Michigan Rogel Cancer Center