Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Mechanical circulatory support with the Pulsecath iVAC2L device

    Device

    The 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

98 Participants
are divided into 2 treatment groups
Group A: Standard-of-Care (without MCS)No intervention 0 interventions
Group B: Pulsecath iVAC2L (with MCS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days

Secondary outcomes

1

PCWP (Δ max)

Time frame
Periprocedural
2

LVEDP (Δ max)

Time frame
Periprocedural
3

CO / CI / CPO (Δ max)

Time frame
Periprocedural
4

SvO2 (Δ max)

Time frame
Periprocedural

Other outcomes

1

Major vascular events

Safety endpoint

Time frame
30 days
2

Limb ischemia

Safety endpoint

Time frame
30 days
3

Bleeding events (BARC 3 and 5)

Safety endpoint

Time frame
30 days
4

Aortic valve injury

Safety endpoint

Time frame
30 days

Sponsors and contacts

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