The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support

Completed

• Conditions: Heart Failure; Cardiomyopathies; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases
• Interventions: Other: No intervention

• Registration Number: NCT04634708
• Lead Sponsor: Berlin Heart GmbH

Brief Summary

The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.

Detailed Description

The study has a prospective, multicenter, international, single arm, observational design.

Study enrollment is expected to take 18 months and subjects will be followed until they reach an outcome or for 45 days on the EXCOR Active driving unit. The overall study duration is expected to be approximately 20 months.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-18
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Pediatric patients meeting all indications as specified in the current version of the instructions for use (IFU) of the EXCOR® Active system,
• Age < 18 years,
• Patient and legal guardian has consented via signature on the study informed consent form,
• Patient is able to get mobilized according to hospital standard and is currently supported with the Ikus driving unit. The decision if a patient is able to get mobilized is at the discretion of the investigator.

Exclusion Criteria

• Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Active system,
• Patient and/or legal representative has not given written consent to participate in the study (non-consent),
• Females of childbearing age who are not on contraceptives or surgically sterile or who are pregnant.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients on EXCOR VAD support	No intervention	-

Primary Outcome Measures

Name	Time	Method
EXCOR Active device performance	52 days

Secondary Outcome Measures

Name	Time	Method
Successful patient outcome rates	Whenever it happens or 52 days	Successful outcome is defined as: * survival to transplant, or; * survival to recovery/successful weaning, or; * survival on EXCOR Pediatric at 45 days post-switch to EXCOR Active.

Trial Locations

Locations (1)

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany