PULsecath mechanicaL Support Evaluation

NCT03200990 | Completed

• 1 other identifier: Pulse version 2.9
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 3

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.

Conditions

Coronary Artery Disease; Heart Failure; Cardiogenic Shock

Keywords

pressure-volume loops; cardiac mechanics; high-risk PCI

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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.

Study Arms (1)

iVAC2L pVAD

EXPERIMENTAL

Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.

Device: iVAC2L pVAD

Interventions

iVAC2L pVAD DEVICE

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.

iVAC2L pVAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (3)

Clinic Pasteur

Toulouse, France

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015CE, Netherlands

Location

Kings College London, St. Thomas' Hospital

London, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35331637 DERIVED

• 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.

  PMID: 34317072 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Nicolas v. Mieghem, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 28, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (1); NL (1)