NCT05428384已完成不适用
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 8
- 主要终点
- Cardiac output estimation
研究概览
简要总结
The investigation will enroll subjects who have been previously implanted with the CardioMEMS™ Pulmonary Artery Sensor. This clinical investigation is twofold; in the first phase (development phase) data collected will be used to complete development of an algorithm that can estimate cardiac output from CardioMEMS™ Heart Failure (HF) System readings. The second phase (validation phase) of this clinical investigation is intended to compare the Cardiac Output estimate from CardioMEMS HF System to Cardiac Output estimates from Cardiac Magnetic Resonance Imaging (reference standard).
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
- •Subject is willing and able to provide written informed consent prior to any clinical investigation-related procedure.
- •Subject is implanted with the CardioMEMS Pulmonary Artery Sensor for a minimum of 3 months at time of consent.
- •Subject is ≥ 18 years of age.
- •Subject is willing and able to undergo several cardiac Magnetic Resonance Imaging scans. This is including but not limited to:
- •Subject must have all Magnetic Resonance Imaging compatible devices
- •Subject must be able to hold their breath during imaging
- •Subject must be free of all metal bodies, fragments, or implants that would prohibit Magnetic Resonance imaging
- •Subject is willing and able to upload Pulmonary Artery pressure information (i.e., take daily CardioMEMS readings and have their hemodynamic information collected at study visits) and comply with the follow-up requirements.
排除标准
- •Subject will receive or is likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 6 months.
- •Subject was implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent.
- •Subject is pregnant or planning to become pregnant in the next 6 months.
- •Subject is enrolled into another trial with an active treatment arm.
- •Subject has significant congenital heart disease that has not been repaired.
- •Subject is implanted with mechanical right heart valve(s).
- •Subject has unrepaired severe valvular disease.
- •Subject has an anticipated life expectancy of < 6 months.
- •Subject has an active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum, or urine).
- •Subject has had a major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent.
- •Subject has any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant Right Heart Catheterization, a history of non-compliance, or any condition that would preclude ability to obtain CardioMEMS Pulmonary Artery Sensor readings and paired cardiac Magnetic Resonance Imaging data from being collected.
- •Subjects who, in the opinion of the investigator, are at-risk for serious adverse reaction to Dobutamine (ex. subjects with idiopathic hypertrophic subaortic stenosis and subjects who have shown previous manifestations of hypersensitivity to Dobutamine) should be excluded from the study.
结局指标
主要结局
Cardiac output estimation
时间窗: 18 months
The primary outcome of this clinical investigation is to estimate Cardiac Output from CardioMEMS HF System data. The estimated Cardiac Output will be evaluated for agreement between the CardioMEMS HF System-derived Cardiac Output and the Cardiac Output values from cardiac Magnetic Resonance Imaging in patients with the CardioMEMS HF System
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
CardioMEMS European Monitoring Study for Heart FailureHeart FailureNCT02693691Abbott Medical Devices239
已完成
不适用
CardioMEMS HF System OUS Post Market StudyLeft-Sided Heart FailureHeart FailureCongestive Heart FailureNCT02954341Abbott Medical Devices321
Enrolling By Invitation
不适用
CardioMEMS HF System Real-World Evidence Post-Approval StudyHeart Failure NYHA Class IIHeart Failure NYHA Class IIINCT06306573Abbott Medical Devices2,500
已完成
不适用
CardioMEMS HF System Post Approval StudyLeft-Sided Heart FailureHeart FailureCongestive Heart FailureNCT02279888Abbott Medical Devices1,214
招募中
不适用
Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)Chronic Heart FailureNCT03020043Johann Wolfgang Goethe University Hospital500