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

Heart Failure Clinical Trial

— E-Motion  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634708
• Other study ID #: E-20-330
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: May 2023
• Source: Berlin Heart GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiovascular Diseases
• Heart Diseases
• Heart Failure
• Ventricular Dysfunction

Intervention

Other:
• No intervention
No intervention due to observational design

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Berlin Heart GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety of the device	Adverse Events and Adverse Device Effects; Serious Adverse Events and Serious Adverse Device Effects	52 days
Other	Mobility	The mobility will be assessed with a patient diary.	52 days
Other	Quality of Life of the Patient and Family	The QoL will be assessed with questionnaires.	52 days
Primary	EXCOR Active device performance		52 days
Secondary	Successful patient outcome rates	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.	Whenever it happens or 52 days