Monitors a Venous Cannula Used With Heart Pump Support
Observes safety of a venous cannula used with heart pumps in people with heart failure.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Munich, GermanySee the site
Where in Germany
- LMU KlinikumMunich, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Berlin Heart GmbH
- Trial code
- NCT04782232
- Record updated
- 17 February 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,; The contraindications of EXCOR VAD apply.