Clinical trial NCT03200990: PULsecath mechanicaL Support Evaluation
Official title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Heart Failure
Cardiogenic Shock
Keywords: pressure-volume loops
cardiac mechanics
high-risk PCI
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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;

Primary outcomes:
measure: Change in Pressure-volume Area (PVA)
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Secondary outcomes:
measure: Change in Cardiac Output
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change on the Mean Pulmonary Capillary Wedge Pressure
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in the PCWP v-wave
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Mean Pulmonary Artery Pressure
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Pulmonary Artery Oxygen Saturation
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Right Atrial Pressure
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Preload-recruitable Stroke Work
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in the Starling Contractile Index
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in End-systolic Wall Stress
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in the first derivative of pressure over time
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Systemic Vascular Resistance
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Pulmonary Vascular Resistance
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Cardiac Power Output
timeFrame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
measure: Change in Hematocrit
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in Hemoglobin
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in Platelet Count
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in haptoglobin
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in total and conjugated bilirubin
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in lactate dehydrogenase
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in hs-troponin
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in creatinephosphokinase
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in creatinophosphokinase MB mass assay
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in N-terminal pro b-type natriuretic peptide
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in serum lactate
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: Change in serum creatinine
timeFrame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
measure: All-cause mortality
timeFrame: 30 days follow up
measure: Acute myocardial infarction
timeFrame: 30 days follow up
measure: Stroke or transient ischemic attack
timeFrame: 30 days follow up
measure: Repeat revascularization
timeFrame: 30 days follow up
measure: Major Bleeding
timeFrame: 30 days follow up
measure: Major vascular complications
timeFrame: 30 days follow up
measure: Acute renal dysfunction
timeFrame: 30 days follow up
measure: Increase in Aortic regurgitation
timeFrame: 30 days follow up
measure: Severe hypotension
timeFrame: First 48 hours after the start of PCI.
measure: Ventricular arrhythmias
timeFrame: 30 days follow up
measure: Angiographic failure
timeFrame: 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.
measure: Time of hospitalization
timeFrame: 30 days follow up
measure: Change in Left ventricular ejection fraction
timeFrame: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinic Pasteur
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South Holland
city: London
country: United Kingdom
facility: Kings College London, St. Thomas' Hospital
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas v. Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dedic 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.