se of mechaNical left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures

Phase 4

Recruiting

• Conditions: Coronairy artery disease; stenotic vessels; 10011082

• Registration Number: NL-OMON53381
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

- Age 18 or older - Multidisciplinary heart team consensus for MCS facilitated
PCI AND - Stabilized after admission for ACS/NSTEMI OR ADHF (SCAI A-B) AND -
LVEF <30% AND - Complex left main disease ( requiring debulking techniques,
2-stent etc,) OR equivalent (ostial LAD and RCX) OR last remaining vessel
(native) with likely prolonged procedural ischemia

Exclusion Criteria

- Contraindications for Pulsecath IVAC2L: a. moderate-severe aortic
regurgitation b. known presence of an LV thrombus (contrast echo/MRI) c. aortic
valve prosthesis d. severe aortic valve stenosis e. 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. - Chronic kidney disease with eGFR <25. - Pregnancy, or suspected
thereof. - BMI > 35

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combined Clinical endpoint:<br /><br>- All-cause death<br /><br>- SCAI stage C-E<br /><br>- Renal replacement therapy<br /><br>- Mechanical ventilation<br /><br>- -Peri or -postprocedural ventricular arrhythmias leading to loss of cardiac<br /><br>output</p><br>