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
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
LMU Klinikum
RECRUITING
Munich
Contact Information
Primary
Thomas Schöndorf, Dr. Dr. PD
clinical.science@berlinheart.de
+49 30 81872600
Backup
Eleonora Dal Sasso, Dr.
clinical.science@berlinheart.de
+49 30 81872600
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 20
Treatments
Patients with failing/absence of the right heart
Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support.
Related Therapeutic Areas
Sponsors
Leads: Berlin Heart GmbH