Pilot Study Evaluating Protek Solo Transseptal ECMO Device for Lung Transplant Candidates with Right Heart Failure from Pulmonary Hypertension

What this Trial Is About

This research aims to evaluate whether transseptal extra-corporeal membrane oxygenation ECMO can safely help patients with pulmonary hypertension-related right heart failure PH-RVF who are waiting for a lung transplant. The study focuses on a specific group of lung transplant candidates with advanced heart and lung conditions, and findings may not apply broadly to all Medicare beneficiaries. The trial is a pilot phase 1 study sponsored by Mayo Clinic. Participants will receive the Protek Solo Transseptal Cannula device, which is inserted through veins in the right and left femoral areas or the right internal jugular vein to provide right ventricle support while they await lung transplant. The study includes patients listed for lung transplantation who require this advanced circulatory support. Treatment is monitored closely during the study. During participation, patients will be assessed for survival until transplant within three weeks, as well as secondary outcomes including adverse events, ECMO support duration, dialysis use, and hospital discharge status over two months. Monitoring includes clinical evaluations and safety assessments to understand how the device performs in this setting. The study runs until December 2028 and involves regular follow-up during the treatment period.

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