NL-OMON53381
Recruiting
Phase 4
se of mechaNical left ventricuLar unlOADing in Complex Higher-risk Indicated Procedures - UNLOAD CHIP
Amsterdam UMC0 sites98 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronairy artery disease
- Sponsor
- Amsterdam UMC
- Enrollment
- 98
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 3
se of mechanical left ventricular unloading in acute decompensated systolic heart failure complicated by cardiogenic shockheart failureshock10019280NL-OMON53204Amsterdam UMC154
Recruiting
Not Applicable
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patientscardiac failureheart failure10019280NL-OMON55596EBR Systems, Inc.30
Recruiting
Not Applicable
Prediction of the recovery in the left ventricular ejection fraction after catheter ablation of atrial fibrillation using pre-procedural troponin Iatrial fibrillation with reduced left ventricular ejection fractionJPRN-UMIN000046170niversity of Fukui60
Not yet recruiting
Not Applicable
MEASUREMENT OF LEFT HEART VOLUME DURING SURGERY USING ECHOCARDIOGRAPHY AND COMPARING THEM WITH GOLD STANDARD RADIOLOGICAL IMAGING MEASUREMENTSHealth Condition 1: I251- Atherosclerotic heart disease of native coronary arteryCTRI/2019/07/020182Sree Chitra Tirunal Institute for Medical Sciences and Technology
Not yet recruiting
Not Applicable
Mechanism of Pacemaker Induced Left Ventricular Dysfunctiopacemaker induced left ventricular dysfunctionTCTR20210321003Self-funded240