Mechanical left ventricular unloading with PulseCath iVAC2L during complex high-risk PCI

Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures

This trial will test whether using the PulseCath iVAC2L pump to support the heart during complex, high-risk PCI helps people with poor left ventricular function avoid low blood pressure and other complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (other)
• Locations: 8 sites (Amsterdam and 7 other locations)
• Trial ID: NCT07380217 on ClinicalTrials.gov

What this trial studies

This is a multicenter interventional study in which patients selected by a multidisciplinary heart team for high-risk percutaneous coronary intervention receive mechanical circulatory support with the PulseCath iVAC2L device during the procedure. The iVAC2L is a pulsatile left ventricular pump that can deliver up to about 2 L/min of forward flow to maintain perfusion while balloons and stents are deployed. Eligible participants are hemodynamically stable adults with complex left main or equivalent disease and reduced left ventricular ejection fraction meeting prespecified thresholds, and they are monitored for peri-procedural hemodynamic stability and device-related complications. The study aims to determine whether LV unloading with the iVAC2L improves intra-procedural stability and safety compared with expected outcomes for similar high-risk procedures.

Who should consider this trial

Good fit: Adults chosen by a heart team for high-risk PCI who are hemodynamically stable and have reduced LVEF (for example LVEF <30% or <35% with moderate MR or <40% with severe MR) and complex left main or equivalent coronary disease are ideal candidates.

Not a fit: Patients in cardiogenic shock, those who are intubated, or those with contraindications to the device such as severe aortic regurgitation, LV thrombus, mechanical aortic valve, severe aortic stenosis, or prohibitive peripheral arterial disease are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce peri-procedural hemodynamic collapse and related complications for patients undergoing complex PCI with poor heart function.

How similar studies have performed: Other mechanical support devices (Impella, IABP) have improved intra-procedural hemodynamics but have not shown clear outcome benefits and are associated with increased complications, while the PulseCath iVAC2L is a newer, pulsatile device with limited outcome data to date.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years AND
* Multidisciplinary heart team consensus for high risk PCI +/- MCS AND
* Hemodynamically stable (SCAI A-B) AND
* LVEF \<30% OR LVEF \<35% with moderate MR OR LVEF \<40% with severe MR AND
* Complex left main disease (calcium modifying techniques deemed necessary OR 2-stent techniques, left dominant system) OR equivalent (ostial LAD and RCX) OR last remaining vessel (native).

Exclusion Criteria:

* Contraindications for Pulsecath IVAC2L:

  1. severe aortic regurgitation
  2. known presence of an LV thrombus (contrast echo/MRI)
  3. Mechanical aorta valve prosthesis
  4. severe aortic valve stenosis
  5. peripheral arterial disease that would preclude placement of the PulseCath iVAC2L device
* Cardiogenic shock defined as either SCAI CSWG stage C-E
* Patient is intubated and mechanically ventilated
* Stroke \<3 months
* Major bleeding event \<3 months
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions.Renal replacement therapy
* Pregnancy, or suspected thereof.
* BMI \> 35
* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures.
* Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention).

Where this trial is running

Amsterdam and 7 other locations

• Amsterdam University Medical Center — Amsterdam, Netherlands (RECRUITING)
• Zuyderland — Geleen, Netherlands (RECRUITING)
• University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
• Leiden University Medical Center — Leiden, Netherlands (RECRUITING)
• Maastricht University Medical Center — Maastricht, Netherlands (RECRUITING)
• Radboud University Medical Center — Nijmegen, Netherlands (RECRUITING)
• Haaglanden Medical Center — The Hague, Netherlands (RECRUITING)
• University Medical Center Utrecht — Utrecht, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Alexander Nap, MD, PhD

Conditions: High-risk PCI, Coronary Artery Disease Risk High, CHIP, Mechanical Circulatory Support, Pulsecath iVAC2L, Pulsecath, iVAC2L