Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
Recruiting · NCT06770023 · Interventional (participants receive a specific treatment) · Lead sponsor: Mayo Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Protek Solo Transseptal Cannula
What this trial is about
The purpose of this study is to determine if transseptal extra-corporeal membrane oxygenation (ECMO) can bridge pulmonary hypertension- right heart failure (PH-RVF) patients to lung transplant safely.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 1 US state.
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States