Recruiting
Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
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.
ClinicalTrials.gov IDNCT06770023
PhasePHASE1
Enrollment4
SponsorMayo Clinic
Age18 Years – 80 Years
SexALL
Conditions studied
Lung Transplant, Pulmonary Hypertension
About this study
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.
Interventions
- Device: Protek Solo Transseptal Cannula — The Protek Solo Transseptal Cannula ECMO cannula will be placed from the right femoral vein and the drainage cannula will be placed from either the left femoral vein or the right internal jugular vein.
Primary outcomes
- Survival until transplant (3 weeks)
Eligibility information
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:
1. central venous pressure (CVP) \> 15 mm Hg
2. global RV dysfunction on echocardiography defined as one of the following:
1. a tricuspid annular plane systolic excursion score of \<14mm
2. an RV diameter at base \>42mm
3. 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 locations
- Mayo Clinic in Florida, Jacksonville, Florida 32224 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.