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Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension
RecruitingPhase 1
A Pilot Study of Transseptal ECMO With the Protek Solo Cannula in Lung Transplant Candidates With Right Heart Failure From Pulmonary Hypertension
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
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.About the 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.
What is being tested
- Protek Solo Transseptal Cannula (device)
Sponsor: Mayo Clinic · Participants: 4 · Started: Dec 11, 2026
Contact the study team
- Ian A Makey, MD · Phone: 9049531048
- Mohammad E Alomari, MD · Phone: 9044283665
Official record on ClinicalTrials.gov — NCT06770023
Locations in the U.S.
| Florida | Mayo Clinic in Florida, Jacksonville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.