Actively Recruiting

All Genders
NCT04782232

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

Led by Berlin Heart GmbH · Updated on 2025-02-17

20

Participants Needed

1

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient or their parent/guardian or legal representative has given written, signed, and dated informed consent
  • Patient meets the indications for RVAD and BVAD use of the EXCOR VAD
  • Patient is on the heart transplant list or eligible for heart transplantation
  • Patient has a body surface area of 1.2 square meters or greater
Not Eligible

You will not qualify if you...

  • Patient or their parent/guardian or legal representative has not given consent
  • Patient has contraindications to the use of the EXCOR VAD

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

LMU Klinikum

Munich, Germany

Actively Recruiting

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Research Team

T

Thomas Schöndorf, Dr. Dr. PD

CONTACT

E

Eleonora Dal Sasso, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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