RecruitingPhase 1NCT06770023

Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension

A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension

Sponsor

Mayo Clinic

Enrollment

4 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Transplant Pulmonary Hypertension

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria22

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 Criteria9

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.

Interventions

DEVICEProtek 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.