Phase
Condition
Chest Pain
Circulation Disorders
Congestive Heart Failure
Treatment
Protek Solo Transseptal Cannula
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Patients that are listed for lung transplantation and have:
PH defined as:
Group 1 Pulmonary arterial hypertension (PAH): Mean pulmonary artery pressure (PAP) ≥ 20 mm Hg, pulmonary capillary wedge pressure (PCWP) < 15 mm Hg, and pulmonary vascular resistance (PVR) ≥ 3 Wood units
Group 3 PH is defined as the presence of chronic lung disease (CLD) and/or hypoxia and mean pulmonary artery pressure (PAP) ≥ 20 mm Hg.
Secondary PH (WHO Group 3) or diagnosis of primary PH (WHO Group 1) (to include Eisenmenger syndrome).
Failing right ventricle function defined as:
a cardiac (CI) index < 2.2 L/min/m^2 despite continuous infusion of high dose inotropes defined as:
Inhaled nitric oxide > 20 ppm and one of the following:
Dobutamine > 10 ug/kg/min x 15 minutes or
Milrinone > 0.5 ug/kg/min x 120 minutes or
Epinephrine > 0.5 ug/kg/min x 15 minutes or
Norepinephrine > 0.5 ug/kg/min x 15 minutes and have one of the following:
central venous pressure (CVP) > 15 mm Hg
global RV dysfunction on echocardiography defined as one of the following:
a tricuspid annular plane systolic excursion score of <14mm
an RV diameter at base >42mm
RV short-axis or midcavity diameter >35mm
Lactate greater than 3 mmol/L
Urine output < 0.5 ml/kg/hour
Age > 18 years old
BMI <35
Informed consent signed by self or legally authorized representative.
Exclusion Criteria
INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
End organ failure defined as: hepatic total bilirubin >5 mg/dL based on lab data within 24 hours prior to transseptal ECMO initiation; renal creatinine >4 mg/dLbased on lab data within the 24 hours prior to transseptal ECMO initiation
Evidence of acute neurologic injury
Active infection defined as two of the following WBC >12,500, positive blood culture, fever
RA thrombus
Thrombolysis within the previous 30 days or known existing coagulopathy such as thrombocytopenia or hemoglobin diseases such as sickle cell anemia or thalassemia
Right heart failure from isolated pulmonary embolism
Right heart failure from coronary artery disease or from left heart failure (WHO Type 2)
Congenital forms of pulmonary hypertension such as tetralogy of fallot or pulmonary vein stenosis.
Study Design
Study Description
Connect with a study center
Mayo Clinic in Florida
Jacksonville, Florida 32224
United StatesActive - Recruiting

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