NCT04480151

Brief Summary

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 13, 2020

Last Update Submit

July 6, 2021

Conditions

Cardiogenic ShockEnd-stage Heart Failure

Keywords

cardiogenic shockend stage heart failurebridge to bridgebridge to decisionleft ventricular assist deviceIMPELLA™ECLS

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation

    Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation

    Day 30 after Left Ventricular Assist Device (LVAD) implantation

Secondary Outcomes (14)

  • Complication and rehabilitation under Short-term Mechanical Circulatory support

    The day of Left Ventricular Assist Device (LVAD) implantation

  • Organ dysfunction before LVAD implantation

    The day before LVAD implantation

  • complication Under LVAD

    The day of Intensive Care Unit (ICU) discharge

  • SOFA score

    The day of Short Term Mechanical Circulatory Support (STMCS) implantation

  • SOFA score

    The day of LVAD implantation

  • +9 more secondary outcomes

Study Arms (2)

IMPELLA™ alone as bridge to LVAD

patients assisted by IMPELLA™ pump alone during the days preceding the implantation of long term LVAD (at least 48 hours for patients for whom an ECLS was previously used)

Other: standard of care

ECLS alone or with IMPELLA™ as bridge to LVAD

patients assisted by ECLS (ExtraCorporeal life support) alone or simultaneously with IMPELLA™ until the implantation of LVAD

Other: standard of care

Interventions

standard of careOTHER

retrospective study: standard of care

ECLS alone or with IMPELLA™ as bridge to LVADIMPELLA™ alone as bridge to LVAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive patients implanted by IMPELLA™ pump or ECLS as a bridge to long duration LVAD between January 2012 and December 2018 in five university hospital centers.

You may qualify if:

  • patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

You may not qualify if:

  • Patient refusing to give access to their medical chart
  • Guardianship and curactorship
  • Deprived of liberty
  • short term mechanical circulatory system weaned before LVAD implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Dijon-Bourgoigne

Dijon, 21079, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Bordeaux

Pessac, 33604, France

Location

CHU de Rennes

Rennes, 35000, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alexandre OUATTARA, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 21, 2020

Study Start

January 20, 2021

Primary Completion

April 21, 2021

Study Completion

April 21, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)