An interventional study of iVAC2L pVAD in Coronary Artery Disease, Heart Failure and Cardiogenic Shock, sponsored by Erasmus Medical Center. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-29.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 32 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.
Device: iVAC2L pVAD
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.
Change in Pressure-volume Area (PVA)
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
Time frame: 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 Output
Numerical continuous variable representing the change in Cardiac Output (CO), 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 CO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: L/min
Time frame: 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
Numerical continuous variable representing the change in Mean Pulmonary Capillary Wedge Pressure (mPCWP), 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 mPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time frame: 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
Numerical continuous variable representing the change in PCWP v-wave (vPCWP), 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 vPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time frame: 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
Numerical continuous variable representing the change in Mean Pulmonary Artery Pressure (mPAP), 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 mPAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time frame: 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
Numerical continuous variable representing the change in Pulmonary Artery Oxygen Saturation, also known as Mixed Oxygen Saturation (SVO2), 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 SVO2 will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: %
Time frame: 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
Numerical continuous variable representing the change in Right Atrial Pressure (RAP), 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 RAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time frame: 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
Numerical continuous variable representing the change in Preload-recruitable Stroke Work (PRSW), 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 PRSW will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg
Time frame: 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
Numerical continuous variable representing the change in the Starling Contractile Index (SCI), 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 SCI will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/ml⋅s
Time frame: 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
Numerical continuous variable representing the change in the End-systolic Wall Stress (WSes), 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 WSes will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
Time frame: 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
Numerical continuous variable representing the change in the first derivative of pressure over time (+dP/dtmax), 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 +dP/dtmax will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/s
Time frame: 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
Numerical continuous variable representing the change in the Systemic Vascular Resistance (SVR), 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 SVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm\^(-5))
Time frame: 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
Numerical continuous variable representing the change in the Pulmonary Vascular Resistance (PVR), 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 PVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm\^(-5))
Time frame: 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
Numerical continuous variable representing the change in the Cardiac Power Output (CPO), 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 CPO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: Watts
Time frame: 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
Numerical continuous variable. Change in Hematocrit (Ht) as an indicative of bleeding or hemolysis. Unit: %
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Hemoglobin
Numerical continuous variable. Change in Hemoglobin (Hb) as an indicative of bleeding or hemolysis. Unit: mmol/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Platelet Count
Numerical continuous variable. Change in Platelet Count as an indicative of bleeding events. Unit: 10\^9/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in haptoglobin
Numerical continuous variable. Change in haptoglobin as an indicative of hemolytic events. Unit: g/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in total and conjugated bilirubin
Numerical continuous variable. Change in total and conjugated bilirubin as an indicative of hemolytic events. Unit: umol/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in lactate dehydrogenase
Numerical continuous variable. Change in lactate dehydrogenase as an indicative of hemolytic events. Unit: U/L.
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in hs-troponin
Numerical continuous variable. Change in hs-troponin as an indicative of myocardial necrosis. Unit: ng/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinephosphokinase
Numerical continuous variable. Change in creatinephosphokinase (CK) as an indicative of myocardial necrosis. Unit: U/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinophosphokinase MB mass assay
Numerical continuous variable. Change in creatinophosphokinase MB mass assay (CKMB-mass) as an indicative of myocardial necrosis. Unit: ug/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in N-terminal pro b-type natriuretic peptide
Numerical continuous variable. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) as an indicative of chamber overload. Unit: pmol/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum lactate
Numerical continuous variable. Change in serum lactate as an indicative of hypoperfusion states. Unit: mmol/L.
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum creatinine
Numerical continuous variable. Change in serum creatinine as an indicative of acute kidney injury. Unit: umol/L
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
All-cause mortality
Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time frame: 30 days follow up
Acute myocardial infarction
According to the "Fourth Universal Definition of Acute Myocardial Infarction". Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time frame: 30 days follow up
Stroke or transient ischemic attack
As per VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time frame: 30 days follow up
Repeat revascularization
As per ARC definition - Circulation. 2007;115:2344-2351. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
Time frame: 30 days follow up
Major Bleeding
Major bleeding (BARC 3 to 5), according to the BARC Bleeding Classification (BARC definitions 2011. Circulation. 2011; 123(23): 2736-47. Time-to-event variable, measured in days.
Time frame: 30 days follow up
Major vascular complications
Major vascular complications (e.g.: arteriovenous fistula, limb ischemia), as per VARC-2 definitions (VARC 2 definitions 2013, J Thorac Cardiovasc Surg 2013;145:6-23) . Time-to-event variable, measured in days.
Time frame: 30 days follow up
Acute renal dysfunction
Acute renal dysfunction (AKIN 1 or above), using the AKIN Classification as described in the VARC-2 definitions (VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23).
Time frame: 30 days follow up
Increase in Aortic regurgitation
Increase in aortic regurgitation by more than one grade (TTE). Binary outcome obtained at the second echocardiogram, performed at discharge.
Time frame: 30 days follow up
Severe hypotension
Severe hypotension (MAP \< 60mmHg for more than 10 minutes despite fluid resuscitation or use of vasoactive amines to maintain MAP ≥ 60 mm Hg), or shock, defined based on the definition from the SHOCK trial (1) SBP ≤ 90mmHg for at least 30 minutes, (2) Need for vasopressors to maintain SBP \> 90mmHg; (3) evidence of end-organ hypoperfusion; (4) Evidence of elevated filling pressures. A similar concept has been applied in the BCIS-1 study to measure procedural instability (JAMA. 2010;304(8):867-874).
Time frame: First 48 hours after the start of PCI.
Ventricular arrhythmias
VT requiring cardioversion and / or need for CPR. Binary outcome, VF at anytime during follow up. Time-to-event analysis, measured in days.
Time frame: 30 days follow up
Angiographic failure
Angiographic failure/ procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation. 2011;124:e574-e651): post PCI TIMI flow \< III, residual stenosis (\>50% post-balloon or \> 10% post stenting), or presence of thrombus, side branch loss or flow limiting dissection. It is a binary outcome (yes/no answer). No time-to-event analysis will be applied.
Time frame: 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
Time to hospital discharge (in days).
Time frame: 30 days follow up
Change in Left ventricular ejection fraction
Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Not a time-to-event variable. Unit: %
Time frame: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Erasmus Medical Center