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

Study Overview
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Brief Summary
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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.

Detailed Description
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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, the follow-up of up to 12 months.

Official Title
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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

Conditions
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Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with failing/absence of the right heart<br>Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support. | Other: No intervention<br>* No intervention due to observational design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality | Short-term mortality | 30 days | 
| Rate of major bleeding | Short-term rate of major bleeding | 30 days | 
| Rate of thrombosis | Short-term rate of thrombosis | 30 days | 
| Survival to heart transplantation | Long-term survival to heart transplantation | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | Safety of the device | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EXCOR Ventricular Assist Device, EXCOR Venous Cannula, Failing Fontan