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

Heart Failure Clinical Trial

— RegiVe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782232
• Other study ID #: E-20-325
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2023
• Source: Berlin Heart GmbH
• Contact: Thomas Schöndorf, Dr. Dr. PD
• Phone: +49 30 81872600
• Email: clinical.science[@]berlinheart.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Univentricular Heart
• Ventricular Dysfunction

Intervention

Other:
• No intervention
No intervention due to observational design

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Berlin Heart GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of mortality	Short-term mortality	30 days
Primary	Rate of major bleeding	Short-term rate of major bleeding	30 days
Primary	Rate of thrombosis	Short-term rate of thrombosis	30 days
Primary	Survival to heart transplantation	Long-term survival to heart transplantation	up to 12 months
Secondary	Rate of adverse events	Safety of the device	up to 12 months