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 (RegiVe)

Berlin Heart

Status: Enrolling

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

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04782232

E-20-325

Details and patient eligibility

About

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.

Full 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, the follow-up of up to 12 months.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Patients with failing/absence of the right heart

Description:

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.

Treatment:

Other: No intervention