Coronary Artery DiseasePULSENCT03200990
PULsecath mechanicaL Support Evaluation
A study testing iVAC2L pVAD in people with Coronary Artery Disease and Heart Failure, run by Erasmus Medical Center at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure, Cardiogenic Shock
- What is being tested?
- iVAC2L pVAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Previous stroke within the last 3 months;
- Major bleeding event within last 3 months;
- Chronic kidney disease with a GFR < 25 mL/min;
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Heart Failure, Cardiogenic Shock
- Being tested
- iVAC2L pVAD
- Keywords
- pressure-volume loops, cardiac mechanics, high-risk PCI
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVAC2L pVADDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| iVAC2L pVAD | Experimental | Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L. Receives: Device: iVAC2L pVAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Secondary outcomes (38)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: %
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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))
Measured: 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))
Measured: 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
Measured: 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: %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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: %
Measured: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startDec 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas v. Mieghem, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200990
- Sponsor's protocol ID
- Pulse version 2.9
- Acronym
- PULSE
- Status last verified
- Mar 2021
- First submitted
- 8 Jun 2017
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.
PubMed 35331637Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.
PubMed 34317072
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PULsecath mechanicaL Support Evaluation (PULSE) - Trial
- ClinicalTrials.gov ID
- NCT03200990
- Acronym / sponsor ID
- PULSE / Pulse version 2.9
- Conditions
- Coronary Artery Disease, Heart Failure, Cardiogenic Shock
- Keywords
- pressure-volume loops, cardiac mechanics, high-risk PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iVAC2L pVAD | Experimental | Device: iVAC2L pVADClinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iVAC2L pVADTo 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. | Device | iVAC2L pVAD |
Primary outcome
Change in Pressure-volume Area (PVA)
Time frame: 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
38 secondary outcomes
Change in Cardiac Output
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Hemoglobin
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Platelet Count
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in haptoglobin
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in total and conjugated bilirubin
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in lactate dehydrogenase
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in hs-troponin
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinephosphokinase
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinophosphokinase MB mass assay
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
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum lactate
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum creatinine
Time frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
All-cause mortality
Time frame: 30 days follow up
Acute myocardial infarction
Time frame: 30 days follow up
Stroke or transient ischemic attack
Time frame: 30 days follow up
Repeat revascularization
Time frame: 30 days follow up
Major Bleeding
Time frame: 30 days follow up
Major vascular complications
Time frame: 30 days follow up
Acute renal dysfunction
Time frame: 30 days follow up
Increase in Aortic regurgitation
Time frame: 30 days follow up
Severe hypotension
Time frame: First 48 hours after the start of PCI.
Ventricular arrhythmias
Time frame: 30 days follow up
Angiographic failure
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 frame: 30 days follow up
Change in Left ventricular ejection fraction
Time frame: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Derived from this study: PubMed 35331637Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.
- Derived from this study: PubMed 34317072Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
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Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Not yet recruiting
TRADENT Scoring Balloon Versus Non-scoring Balloon for Lesion Preparation in DCB-Based Coronary Intervention
Coronary Artery Disease (CAD)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas v. Mieghem, MD, PhD principal investigator
Erasmus Medical Center
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iVAC2L pVAD in people with Coronary Artery Disease and Heart Failure, run by Erasmus Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure-volume Area (PVA) (time frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200990, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.