Status:
RECRUITING
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
Lead Sponsor:
Berlin Heart GmbH
Conditions:
Heart Failure
Univentricular Heart
Eligibility:
All Genders
Brief 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 enab...
Detailed Description
The registry study has an observational, prospective, international, multi-center, non-randomized design. The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, th...
Eligibility Criteria
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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04782232
Start Date
June 1 2021
End Date
September 1 2027
Last Update
February 17 2025
Active Locations (1)
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1
LMU Klinikum
Munich, Germany