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
Sponsored by Berlin Heart GmbH
About this trial
Last updated 3 years ago
Study ID
E-20-325
Status
Recruiting
Type
Observational [Patient Registry]
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 months ago
What is this trial about?
The purpose of the study is to monitor the clinical safety and performance of the EXCOR
Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of
identified risks, to enable detecting emerging risks and to assess clinical improvement on
both short- and long-term.
What are the participation requirements?
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.