RecruitingNCT04782232

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


Sponsor

Berlin Heart GmbH

Enrollment

20 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This registry study tracks the safety and feasibility of a specialized heart assist device — a venous cannula used with the EXCOR ventricular assist device (VAD) — in patients whose right side of the heart is failing or absent. It collects data on how these devices work in real-world use. **You may be eligible if...** - You or your legal guardian has provided written consent - You meet clinical criteria for use of a right ventricular assist device (RVAD) or biventricular assist device (BVAD) with the EXCOR VAD system - You are on a transplant waiting list or are eligible for a heart transplant - Your body surface area (a measure of body size) is at least 1.2 m² **You may NOT be eligible if...** - Consent was not given by you or your legal guardian - You have contraindications (medical reasons not to use) the EXCOR VAD system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention due to observational design


Locations(1)

LMU Klinikum

Munich, Germany

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NCT04782232


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