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
Observational Study
Heart Failure
Univentricular Heart
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Berlin Heart GmbH · Industry
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About This Trial
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.
Trial Locations
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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 eligibl…
Contacts