Actively Recruiting
Use of Mechanical Left Ventricular Unloading in Complex Higher-risk Indicated Procedures
Led by Amsterdam UMC, location VUmc · Updated on 2026-02-02
98
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
P
Pulsecath BV.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial focuses on patients undergoing high-risk percutaneous coronary intervention (PCI) due to complex coronary artery disease and reduced heart function. Researchers aim to study whether using a mechanical heart pump called the Pulsecath iVAC2L during PCI improves patient outcomes compared to PCI without this support. This device is designed to help the heart pump blood more effectively during the procedure, which can be risky due to temporary blockage of blood flow. Participants will be randomly assigned to receive high-risk PCI with or without the Pulsecath iVAC2L mechanical circulatory support device. The Pulsecath iVAC2L is a pulsatile pump placed in the left ventricle that ejects blood into the aorta, potentially maintaining better blood flow and vascular function compared to other devices. The study compares standard PCI without support to PCI with this device to evaluate safety and effectiveness in reducing complications. During the study, patients will be monitored for various outcomes including death, cardiogenic shock, need for kidney therapy, mechanical ventilation, and heart rhythm problems within 30 days. Researchers will also assess heart and lung pressure changes, cardiac output, blood oxygen levels, procedural success, hospital stay length, and cardiovascular events. Participants will be followed closely through hospitalization and up to 30 days after PCI to evaluate safety and clinical outcomes.
CONDITIONS
Brief Title
Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Heart team agrees you need high-risk PCI with or without mechanical circulatory support
- Hemodynamically stable (SCAI A-B)
- Left ventricular ejection fraction (LVEF) less than 30%, or less than 35% with moderate mitral regurgitation, or less than 40% with severe mitral regurgitation
- Complex left main coronary disease or equivalent (ostial LAD and RCX) or last remaining vessel with specific technical needs
You will not qualify if you...
- Severe aortic regurgitation
- Known left ventricular thrombus
- Mechanical aortic valve prosthesis
- Severe aortic valve stenosis
- Peripheral arterial disease preventing device placement
- Cardiogenic shock (SCAI stages C-E)
- Currently intubated and on mechanical ventilation
- Stroke within last 3 months
- Major bleeding event within last 3 months
- History of bleeding disorders or refusal of blood transfusions
- Receiving renal replacement therapy
- Pregnancy or suspected pregnancy
- Body mass index over 35
- Other medical, social, or psychological issues affecting consent or compliance
- Belonging to vulnerable populations unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo high-risk percutaneous coronary intervention (PCI) with or without the use of the Pulsecath iVAC2L mechanical circulatory support device during the procedure.
1 procedure visit (in-person)
Duration - Up to 30 days post-procedure
Participants are monitored for safety and clinical outcomes including complications, cardiac function, and adverse events after the PCI procedure.
Approximately 3 to 5 follow-up visits (in-person or remote)
Trial Site Locations
Total: 8 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
2
Zuyderland
Geleen, Netherlands
Actively Recruiting
3
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
4
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
5
Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
6
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
7
Haaglanden Medical Center
The Hague, Netherlands
Actively Recruiting
8
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
A
Alexander Nap, MD, PhD
T
Tijmen H. Ris, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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