NCT06007963

Brief Summary

The purpose of the study is to evaluate the safety, efficacy and clinical usefulness of a mechanical support strategy with the impella device.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 3, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 23, 2023

Status Verified

December 1, 2022

Enrollment Period

2.9 years

First QC Date

April 3, 2019

Last Update Submit

August 22, 2023

Conditions

Shock, Cardiogenic

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Description: mortality: as assessed via patient file, contact with patient, general physician or family memeber

    30 day and 1 year

Secondary Outcomes (1)

  • Myocardial recovery

    30 dat and 1 year

Interventions

Treatment with impella device.PROCEDURE

Impella percutaneous mechanical supported patients will be included after revision to support.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A/ Awake patients will only be asked for consent after getting oral and written information. B/ Ventilated patients will be included after consent is obtained from legal representative. After improvent of patients status consent will be obtained from the patient.

You may qualify if:

  • Patients admitted for cardiogenic shock (defined as SBP \<90 mmHg without vasopressors/inotropics or elevated serum lactate).
  • AND
  • Treatment with Impella device

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven, Gasthuisberg

Leuven, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Coagulation tests

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Tom Adriaenssens, MD PhD

    Universitaire Ziekenhuizen KU Leuven

    STUDY CHAIR

Central Study Contacts

Tom Adriaenssens, MD PhD

CONTACT

016/341392tom.adriaenssens@uzleuven.be

Walter Desmet, Prof. dr.

CONTACT

walter.desmet@uzleuven.be

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

August 23, 2023

Study Start

January 29, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 23, 2023

Record last verified: 2022-12

Locations

BE(1)