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Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
Sponsor: Amsterdam UMC, location VUmc
Summary
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.
Official title: Use of mechaNical Left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
98
Start Date
2024-01-25
Completion Date
2027-03-01
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
Mechanical circulatory support with the Pulsecath iVAC2L 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.
Locations (8)
Amsterdam University Medical Center
Amsterdam, Netherlands
Zuyderland
Geleen, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands