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

Recruiting

• Conditions: Heart Failure; Univentricular Heart; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

• Registration Number: NCT04782232
• Lead Sponsor: Berlin Heart GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-2-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient or his/her parent/guardian or legally authorized representative has given<br> the consent by means of a written, signed and dated informed consent form,<br><br> - The indications on RVAD and BVAD use of the EXCOR VAD apply,<br><br> - Patient shall be on transplant list or at least eligible for HTx,<br><br> - BSA (body surface area) greater than or equal to 1.2 m².<br><br>Exclusion Criteria:<br><br> - Patient or his/her parents/legal guardian or legally authorized guardian has not<br> given the consent,<br><br> - The contraindications of EXCOR VAD apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of mortality;Rate of major bleeding;Rate of thrombosis;Survival to heart transplantation

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events