NCT04634708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

November 12, 2020

Last Update Submit

May 3, 2023

Conditions

Heart FailureCardiomyopathiesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Keywords

EXCOR Ventricular Assist DeviceEXCOR ActiveMobilizationPediatric

Outcome Measures

Primary Outcomes (1)

  • EXCOR Active device performance

    52 days

Secondary Outcomes (1)

  • Successful patient outcome rates

    Whenever it happens or 52 days

Other Outcomes (3)

  • Safety of the device

    52 days

  • Mobility

    52 days

  • Quality of Life of the Patient and Family

    52 days

Study Arms (1)

Pediatric patients on EXCOR VAD support

Other: No intervention

Interventions

No interventionOTHER

No intervention due to observational design

Pediatric patients on EXCOR VAD support

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Twenty patients supported with the EXCOR® VAD. Patients must meet the eligibility criteria as specified and must not meet the exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

MeSH Terms

Conditions

Heart FailureCardiomyopathiesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 18, 2020

Study Start

November 1, 2020

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

DE(1)