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)

February 9, 2023 updated by: Berlin Heart GmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Munich, Germany
        • Recruiting
        • LMU Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with failing/absence of the right heart
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
No intervention due to observational design

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berlin Heart GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

November 1, 2024

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (ACTUAL)

March 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-20-325

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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