PULsecath mechanicaL Support Evaluation (PULSE) - Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Change in Pressure-volume Area (PVA)
研究概览
简要总结
The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.
详细描述
This is a mechanistic exploratory study. The objective is to determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. These specific patterns are so far unknown. Knowledge of optimal patterns may help in determining the ideal circulatory device platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patient is ≥ 18 years;
- •Informed Consent must be signed by the patient, prior to HR-PCI;
- •The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
- •Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.
排除标准
- •No written informed consent;
- •Left ventricular thrombus;
- •Interventricular septal defect;
- •Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery;
- •Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
- •Cardiogenic shock;
- •Previous stroke within the last 3 months;
- •Major bleeding event within last 3 months;
- •Chronic kidney disease with a GFR < 25 mL/min;
研究组 & 干预措施
iVAC2L pVAD
Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.
干预措施: iVAC2L pVAD (Device)
结局指标
主要结局
Change in Pressure-volume Area (PVA)
时间窗: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Myocardial Oxygen Consumption (MVO2) following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVA will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.mL
次要结局
- Change in Cardiac Output(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change on the Mean Pulmonary Capillary Wedge Pressure(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in the PCWP v-wave(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Mean Pulmonary Artery Pressure(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Pulmonary Artery Oxygen Saturation(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Right Atrial Pressure(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Preload-recruitable Stroke Work(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in the Starling Contractile Index(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in End-systolic Wall Stress(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in the first derivative of pressure over time(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Systemic Vascular Resistance(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Pulmonary Vascular Resistance(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Cardiac Power Output(From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.)
- Change in Hematocrit(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in Hemoglobin(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in Platelet Count(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in haptoglobin(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in total and conjugated bilirubin(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in lactate dehydrogenase(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in hs-troponin(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in creatinephosphokinase(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in creatinophosphokinase MB mass assay(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in N-terminal pro b-type natriuretic peptide(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in serum lactate(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- Change in serum creatinine(From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.)
- All-cause mortality(30 days follow up)
- Acute myocardial infarction(30 days follow up)
- Stroke or transient ischemic attack(30 days follow up)
- Repeat revascularization(30 days follow up)
- Major Bleeding(30 days follow up)
- Major vascular complications(30 days follow up)
- Acute renal dysfunction(30 days follow up)
- Increase in Aortic regurgitation(30 days follow up)
- Severe hypotension(First 48 hours after the start of PCI.)
- Ventricular arrhythmias(30 days follow up)
- Angiographic failure(Assessed at the end of the PCI. This time point (end of PCI) can be variable and is estimated in 40 to 270 minutes after the beginning of the procedure.)
- Time of hospitalization(30 days follow up)
- Change in Left ventricular ejection fraction(From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.)
研究者
Nicolas van Mieghem
MD,PhD, Cardiologist, Principal Investigator
Erasmus Medical Center