Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing or Absent Right Heart

What this Trial Is About

This research aims to observe the safety and performance of the EXCOR Venous Cannula used in EXCOR Ventricular Assist Device (VAD) therapy for patients with failing or absent right heart function. It focuses on monitoring known risks, detecting new risks, and assessing clinical improvement over both short and long periods. The study is designed as an international, multi-center, non-randomized registry lasting 42 months, including an enrollment period of 28 months and follow-up of up to 12 months. Participants are patients with acute or chronic heart failure that cannot be controlled by standard treatment, classified as stage III or IV by the New York Heart Association (NYHA). These patients require short-term to long-term right ventricular or biventricular support. Since this is an observational study, no additional intervention is given beyond usual care with the EXCOR VAD therapy and the novel venous cannula. During the study, researchers will collect data on safety and effectiveness by tracking outcomes such as 30-day mortality, major bleeding, thrombosis rates, and survival to heart transplantation up to 12 months. Adverse events will be recorded throughout the follow-up period. Participants will be monitored with clinical assessments and data collection to help ensure ongoing evaluation of the device's performance and patient outcomes.

Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart