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

Recruiting now

Conditions studied: Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT04782232

Run by

Berlin Heart GmbH

People needed

20

Starts

2021-06-01

Expected to finish

2027-09-01

Last updated by the study team

2025-02-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
• The contraindications of EXCOR VAD apply.

Where it is running

• LMU Klinikum — Munich, Germany (enrolling)

Full record on ClinicalTrials.gov

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