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Recruiting Phase 1 NCT06770023

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

Trial Parameters

Condition Lung Transplant
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 4
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2026-06-11
Completion 2027-12
Interventions
Protek Solo Transseptal Cannula

Brief 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 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

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