NCT04951999

Brief Summary

The primary objective of this study is to determine whether preserved pulsatility for patients supported by CF-LVAD (continuous flow Left Ventricular Assist Device) is associated with less acquired deficiency of the Von Willebrand factor, a blood glycoprotein involved in hemostasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 14, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 2, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2024

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

June 14, 2021

Last Update Submit

August 21, 2025

Conditions

End-stage Heart Failure

Keywords

LVADpulsatility indexVon Willebrand Factor

Outcome Measures

Primary Outcomes (1)

  • Von Willebrand factor high molecular weight multimers (HMWM) ratio

    Comparison of Von Willebrand factor high molecular weight multimers (HMWM) ratio at LVAD pre-implantation and at day 30. Measure of an correlation between preserved pulsatility and the HMWM ratio evolution during the first month after implantation.

    30 days after LVAD IMPLANTATION

Secondary Outcomes (10)

  • Severe postoperative gastrointestinal bleeding

    6 months

  • Post-operative right ventricular failure

    6 months

  • Platelet dysfunction

    6 months

  • Post-operative transient or permanent ischemic attack

    6 months

  • Vascular endothelium dysfunction

    6 months

  • +5 more secondary outcomes

Study Arms (1)

Blood sampling

OTHER
Other: Blood sampling

Interventions

Blood samplingOTHER

For 10 visits (out of the 12 of the protocol), \~40 ml of blood is sampled for research purposes in addition to care sampling.

Blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age
  • Patients for whom a decision to implant a left-sided monoventricular assist has been retained after discussion in the RCP of heart failure, transplantation and circulatory assistance (whatever the therapeutic strategy envisaged: waiting for transplantation, recovery or destination therapy).
  • Patients affiliated to a social security system (beneficiaries or beneficiaries entitled to benefits, excluding AME)
  • Signature of an informed consent by the patient or by the trusted person, or a close relative, if the patient is not able to do so

You may not qualify if:

  • Heart transplant patients
  • Patients who already had LVAD
  • Chronic renal failure patients on dialysis
  • Patients refusing to give informed consent
  • Patients deprived of liberty or under legal protection (guardianship, curators)
  • Pregnant or breastfeeding women
  • Ongoing participation in another intervention research protocol except LEVOECMO project (NCT04728932) and ANCHOR project (NCT04184635)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupement Hospitalier pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Guillaume LEBRETON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

July 7, 2021

Study Start

December 2, 2021

Primary Completion

July 24, 2024

Study Completion

July 24, 2024

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

FR(1)