heart failure right ventricular failure
Conditions
Interventions
after evaluation of in-and exclusion criteria and after obtaining informed
consent, the Impella RP percutaneous right ventricular assist device is
implanted in patients with RV failure refractory to
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >18 years of age - Setting: post-LVAD, post-cardiotomy, post-myocardial infarction - Refractory RV failure, defined as a cardiac index of 10ug/kg/min or equivalent for >120 minutes) or the administration of >1 vasopressor/inotrope AND at least 1 of the following: -central venous pressure (CVP) >18 mmHg -CVP/pulmonary capillary wedge pressure or left atrial pressure ratio of >0.63 -global echocardiographic RV dysfunction, defined as a tricuspid annular systolic excursion (TAPSE) of 42 mm or RV short-axis/midcavity diameter of >35 mm
Exclusion criteria
Exclusion criteria: Definite exclusion criteria -profound cardiogenic shock, defined as a cardiac index of 10 -the presence of a thrombus in the right atrium, right ventricle or pulmonary artery -mechanical prosthetic tricuspid or pulmonary valve -severe tricuspid or pulmonary valve stenosis -pulmonary embolism -anatomic conditions precluding pump insertion -documented deep venous thrombosis or presence of an inferior vena cava filter;Relative exclusion criteria -severe pulmonary hypertension, defined as a systolic pulmonary artery pressure of >60mmHg -RV failure post-cardiac transplant -severe tricuspid or pulmonary valve regurgitation -severe active infection, defined as 2 or more of the following: a temperature of >38.5 C or 12 000 or 90 bpm and respiratory rate of >22/min -known coagulopathy -implantation of permanent pacemaker within three months before study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: the occurrence of bleeding (BARC type 2 and above) including tamponade & access site, hemolysis, thrombus formation in RA/RV/PA, right heart valve dysfunction, and arrhythmias up to 30 days after implantation Primary efficacy endpoint: improvements in cardiac index, inotrope dosage, LVAD flow, pump parameters, urine production, lactate and SvO2 compared to baseline and 4 and 24 hours after implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety endpoint: MACE @ 30 days Secondary efficacy endpoints: • Successful weaning • Duration of implantation procedure • TAPSE, S RV and RV diameters compared to baseline at 24 and 48 hours after implantation, after device removal and at 30 days/before hospital discharge • ICU and hospital length of stay • Survival at 30 days and 6 months | — |
Countries
Netherlands
Outcome results
None listed