We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PULsecath mechanicaL Support Evaluation (PULSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200990
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Nicolas van Mieghem, Erasmus Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Heart Failure Cardiogenic Shock Device: iVAC2L pVAD Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: iVAC2L pVAD
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]
    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

  2. 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. ]
    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.

  3. 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. ]
    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.

  4. 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. ]
    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.

  5. 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. ]
    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: %

  6. 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. ]
    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.

  7. 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. ]
    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

  8. 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. ]
    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

  9. 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. ]
    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.

  10. 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. ]
    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

  11. 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. ]
    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))

  12. 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. ]
    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))

  13. 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. ]
    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

  14. Change in Hematocrit [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in Hematocrit (Ht) as an indicative of bleeding or hemolysis. Unit: %

  15. Change in Hemoglobin [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in Hemoglobin (Hb) as an indicative of bleeding or hemolysis. Unit: mmol/L

  16. Change in Platelet Count [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in Platelet Count as an indicative of bleeding events. Unit: 10^9/L

  17. Change in haptoglobin [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in haptoglobin as an indicative of hemolytic events. Unit: g/L

  18. Change in total and conjugated bilirubin [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in total and conjugated bilirubin as an indicative of hemolytic events. Unit: umol/L

  19. Change in lactate dehydrogenase [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in lactate dehydrogenase as an indicative of hemolytic events. Unit: U/L.

  20. Change in hs-troponin [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in hs-troponin as an indicative of myocardial necrosis. Unit: ng/L

  21. Change in creatinephosphokinase [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in creatinephosphokinase (CK) as an indicative of myocardial necrosis. Unit: U/L

  22. Change in creatinophosphokinase MB mass assay [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in creatinophosphokinase MB mass assay (CKMB-mass) as an indicative of myocardial necrosis. Unit: ug/L

  23. 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. ]
    Numerical continuous variable. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) as an indicative of chamber overload. Unit: pmol/L

  24. Change in serum lactate [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in serum lactate as an indicative of hypoperfusion states. Unit: mmol/L.

  25. Change in serum creatinine [ Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI. ]
    Numerical continuous variable. Change in serum creatinine as an indicative of acute kidney injury. Unit: umol/L

  26. All-cause mortality [ Time Frame: 30 days follow up ]
    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.

  27. Acute myocardial infarction [ Time Frame: 30 days follow up ]
    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.

  28. Stroke or transient ischemic attack [ Time Frame: 30 days follow up ]
    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.

  29. Repeat revascularization [ Time Frame: 30 days follow up ]
    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.

  30. Major Bleeding [ Time Frame: 30 days follow up ]
    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.

  31. Major vascular complications [ Time Frame: 30 days follow up ]
    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.

  32. Acute renal dysfunction [ Time Frame: 30 days follow up ]
    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).

  33. Increase in Aortic regurgitation [ Time Frame: 30 days follow up ]
    Increase in aortic regurgitation by more than one grade (TTE). Binary outcome obtained at the second echocardiogram, performed at discharge.

  34. Severe hypotension [ Time Frame: First 48 hours after the start of PCI. ]
    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).

  35. Ventricular arrhythmias [ Time Frame: 30 days follow up ]
    VT requiring cardioversion and / or need for CPR. Binary outcome, VF at anytime during follow up. Time-to-event analysis, measured in days.

  36. 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. ]
    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.

  37. Time of hospitalization [ Time Frame: 30 days follow up ]
    Time to hospital discharge (in days).

  38. Change in Left ventricular ejection fraction [ Time Frame: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days. ]
    Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Not a time-to-event variable. Unit: %



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is ≥ 18 years;
  2. Informed Consent must be signed by the patient, prior to HR-PCI;
  3. The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
  4. 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.

Exclusion Criteria:

  1. No written informed consent;
  2. Left ventricular thrombus;
  3. Interventricular septal defect;
  4. Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery;
  5. Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
  6. Cardiogenic shock;
  7. Previous stroke within the last 3 months;
  8. Major bleeding event within last 3 months;
  9. Chronic kidney disease with a GFR < 25 mL/min;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200990


Locations
Layout table for location information
France
Clinic Pasteur
Toulouse, France
Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015CE
United Kingdom
Kings College London, St. Thomas' Hospital
London, United Kingdom
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Nicolas v. Mieghem, MD, PhD Erasmus Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nicolas van Mieghem, MD,PhD, Cardiologist, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03200990    
Other Study ID Numbers: Pulse version 2.9
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nicolas van Mieghem, Erasmus Medical Center:
pressure-volume loops
cardiac mechanics
high-risk PCI
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Shock, Cardiogenic
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Shock