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

What this Trial Is About

Researchers are evaluating whether transseptal extra-corporeal membrane oxygenation (ECMO) can safely support patients with pulmonary hypertension and right heart failure until they receive a lung transplant. This pilot phase 1 study focuses on lung transplant candidates experiencing right ventricular failure due to pulmonary hypertension. The study aims to understand survival and safety outcomes in this specific group, with findings to be shared regardless of result direction. The intervention involves using the Protek Solo Transseptal Cannula, which is placed via the right femoral vein with drainage through either the left femoral vein or the right internal jugular vein. Participants are those on the lung transplant list who progress to needing right ventricular support. This treatment is studied over a period including at least 3 weeks to assess survival until transplant, with additional monitoring up to 2 months for adverse events, ECMO support duration, dialysis needs, and hospital discharge. Participants will be monitored regularly with clinical assessments during the study period. Researchers will track survival until transplant as the primary outcome within 3 weeks. Secondary outcomes include the frequency of adverse events, duration on ECMO, dialysis use, and hospital discharge status over 2 months. The total study duration extends until December 2028, with results planned to be published after peer review. Participants' safety and treatment progress will be closely followed throughout this time.

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