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

Launched by BERLIN HEART GMBH · Mar 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the EXCOR Venous Cannula, which is used to support patients with serious heart problems, particularly those who have issues with the right side of their heart or have heart failure. The goal of the trial is to monitor how safe and effective this device is when used with another treatment called EXCOR VAD therapy. Researchers want to ensure that any risks associated with the device are well understood and to see if patients show improvements in their heart health over time.

To participate in this trial, patients need to meet certain criteria. They must be on a waiting list for a heart transplant or be eligible for one, and their body size must be large enough for the device to be used safely. Parents or guardians must also give permission for younger participants. Throughout the study, patients will be closely monitored, and the researchers will be looking for both short-term and long-term health improvements. It's important for potential participants and their families to understand that the main focus is on safety and effectiveness, which can help inform future treatments for heart disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
• • The indications on RVAD and BVAD use of the EXCOR VAD apply,
• • Patient shall be on transplant list or at least eligible for HTx,
• • BSA (body surface area) greater than or equal to 1.2 m².
• Exclusion Criteria:
• • Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
• • The contraindications of EXCOR VAD apply.