Registry to evaluate the safety of a new venous cannula for patients with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to monitor the clinical safety and performance of the EXCOR Venous Cannula used in conjunction with EXCOR Ventricular Assist Device (VAD) therapy. The study will assess both short- and long-term clinical improvements while identifying and managing potential risks associated with the device. Conducted over 42 months, it includes an enrollment period of 28 months and follow-up of up to 12 months across multiple international centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• LMU Klinikum
  Munich, Germany Recruiting

Study contacts

• Study coordinator: Thomas Schöndorf, Dr. Dr. PD
• Email: clinical.science@berlinheart.de
• Phone: +49 30 81872600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.