Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure

The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

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Key information

Conditions

Heart Failure Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, 59037, France

About this study

This study was designed to understand the Von Willebrand Factor (VWF) abnormalities observed in association with implantation of different devices in cardiovascular diseases (percutaneous valve replacement and circulatory support devices).

The main objective of the study was to describe the time-course of VWF abnormalities onset/offset during implantation of devices in cardiovascular diseases.

Adult patients > 18 years who need a CF-LVAD or trans-aortic valve implantation are included in this cohort; Blood samples are obtained just before procedures

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients > 18 years who need a mechanical circulatory support due to advanced heart failure or undergoing trans-aortic-valve-replacement to treat aortic stenosis.
Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion criteria

Patient with a known severe bleeding disorder
Patient refusal or environment
Minor patients
Pregnant women

Treatment and study plan

cardiac devices

Device

patients receiving mechanical circulatory support or undergoing trans aortic valve replacement

Other names: trans aortic valve replacement, mechanical circulatory support

Primary outcomes

Von Willebrand factor (VWF) multimer defects

Time frame: 180 minutes after device implantation

VWF multimeric analysis is performed by electrophoresis. The results of HMW-multimers are expressed as the relative amount of the largest multimers (mer>15) of the sample compared with those of the normal pooled plasma (NPP standard human plasma Siemens healthcare diagnostics, Marburg, Germany, coefficient of variation=11%) present on each gel. 4-6 With this method the HMW-multimer ratio is defined as the HMW-multimers (>15-mer) in patient plasma sample divided by HMW-multimers in normal pool plasma, the HMW-multimer ratio of normal pooled plasma is 1 (by definition) and an HMW-multimer defect is defined as a reduced HMW-multimer-ratio (<1).

Secondary outcomes

platelet function analyser- ADP (PFA-ADP) closure time

Time frame: 5, 15,30, 60 minutes; day 1 , day 7 after device implantation

The PFA test is initially performed with the Collagen/Epinepherine membrane. A normal Col/ADP closure time (<180 seconds) excludes the presence of a significant platelet function defect.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow

Acronym: WiTAVi

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2018
First posted: Dec 11, 2015
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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