About this trial
If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and the placement of a stent. PCI is a commonly performed and safe procedure. However, in your case, the procedure is more complicated than usual due to the location and nature of the narrowing, the required technique for the intervention, and the fact that your heart function is reduced. As a result, your PCI will carry a higher risk than usual.
During the procedure, balloons are inflated to clear the blockage, and a stent is placed to keep the artery open. This temporarily reduces or even stops the blood and oxygen supply to a large portion of the heart. This moment presents a higher risk for complications, such as low blood pressure or cardiac arrest. As a result, the heart may not pump blood effectively throughout the body, which can lead to oxygen deprivation in other organs.
To help the heart in this situation, it is possible to insert a mechanical heart pump during the procedure. This form of support is introduced via an artery in the groin into your left ventricle. The pump helps the heart function and may improve the circulation to the body's organs. On the other hand, the placement of the pump increases the chance of complications. Therefore, there are both potential benefits and risks. It is currently unclear whether PCI with the temporary pump can be performed more safely than without it.
This study aims to investigate whether mechanical circulatory support, specifically with the Pulsecath iVAC2L, leads to improved outcomes for patients undergoing high-risk PCI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
severe aortic regurgitation
known presence of an LV thrombus (contrast echo/MRI)
Mechanical aorta valve prosthesis
severe aortic valve stenosis
Trial design
Parallel
Treatments tested in this trial
Mechanical circulatory support with the Pulsecath iVAC2L device
DeviceThe Pulsecath iVAC2L is a pulsatile pump, placed in the left ventricle, that ejects blood into the ascending aorta at a flow up to 2L/min. Theoretically, pulsatility maintains the physiological vascular responses and endothelial function at the level of the -systemic and -micro circulation and might offer benefit when compared to continues flow devices such as Impella. In contrast, IABP (which also offers pulsatile support), lacks the possibility of active unloading. Therefore, the combination of those features in the PulseCath iVAC2L is unique.
Treatment groups
Trial outcomes
Primary outcomes
Combined endpoint: - All-cause death - Cardiogenic shock (SCAI stage C-E) - (Need for) renal replacement therapy - (Need for) mechanical ventilation - Ventricular arrhythmias leading to loss of cardiac output requiring CPR
Secondary outcomes
PCWP (Δ max)
LVEDP (Δ max)
CO / CI / CPO (Δ max)
SvO2 (Δ max)
Other outcomes
Major vascular events
Safety endpoint
Limb ischemia
Safety endpoint
Bleeding events (BARC 3 and 5)
Safety endpoint
Aortic valve injury
Safety endpoint
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Amsterdam UMC, location VUmc
Lead sponsor
Pulsecath BV.
Collaborator