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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

Recruitingn/aAges any - anyAllBerlin Heart GmbH
NCT04782232 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • No intervention
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Where

1 site
LMU Klinikum
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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