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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04782232

Acronym

RegiVe

Enrollment

Registered

2021-03-04

Start date

2021-06-01

Completion date

2027-09-30

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

EXCOR Ventricular Assist Device, EXCOR Venous Cannula, Failing Fontan

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 enable detecting emerging risks and to assess clinical improvement on both short- and long-term.

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, the follow-up of up to 12 months.

Interventions

OTHERNo intervention

No intervention due to observational design

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Rate of adverse events	up to 12 months	Safety of the device

Countries

Germany

Contacts

Primary ContactThomas Schöndorf, Dr. Dr. PD

clinical.science@berlinheart.de+49 30 81872600

Backup ContactEleonora Dal Sasso, Dr.