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NCT Number: NCT04782232

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Univentricular Heart Ventricular Dysfunction

Sex eligibility

All sexes

Study type

Observational

Primary location

LMU Klinikum

Munich, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention due to observational design

Primary outcomes

  1. Rate of mortality

    Time frame: 30 days

    Short-term mortality

  2. Rate of major bleeding

    Time frame: 30 days

    Short-term rate of major bleeding

  3. Rate of thrombosis

    Time frame: 30 days

    Short-term rate of thrombosis

  4. Survival to heart transplantation

    Time frame: up to 12 months

    Long-term survival to heart transplantation

Secondary outcomes

  1. Rate of adverse events

    Time frame: up to 12 months

    Safety of the device

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Dal Sasso, Dr.

CONTACT

[email protected]

+49 30 81872600

Thomas Schöndorf, Dr. Dr. PD

CONTACT

[email protected]

+49 30 81872600

Sponsors and collaborators

Lead sponsor

Berlin Heart GmbH

Industry

Registry information

Acronym: RegiVe

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2021
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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