Clinical trial NCT02628509: Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure
Official title: Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Aortic Stenosis
Keywords: Acquired Von Willebrand
Trans aortic valve replacement
mechanical circulatory support
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving mechanical circulatory support or undergoing aortic valve replacement

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Von Willebrand factor (VWF) multimer defects
timeFrame: 180 minutes after device implantation
Secondary outcomes:
measure: platelet function analyser- ADP (PFA-ADP) closure time
timeFrame: 5, 15,30, 60 minutes; day 1 , day 7 after device implantation
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: Lille University Hospital
name: Sophie Susen, MD, PhD
role: STUDY_CHAIR
References:
citation: Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.
citation: Vincent F, Spillemaeker H, Kyheng M, Belin-Vincent C, Delhaye C, Pierache A, Denimal T, Verdier B, Debry N, Moussa M, Schurtz G, Porouchani S, Cosenza A, Juthier F, Pamart T, Richardson M, Coisne A, Hertault A, Sobocinski J, Modine T, Pontana F, Duhamel A, Labreuche J, Van Belle E. Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison. J Am Heart Assoc. 2020 Mar 17;9(6):e014916. doi: 10.1161/JAHA.119.014916. Epub 2020 Mar 16.
citation: Van Belle E, Rauch A, Vincent F, Robin E, Kibler M, Labreuche J, Jeanpierre E, Levade M, Hurt C, Rousse N, Dally JB, Debry N, Dallongeville J, Vincentelli A, Delhaye C, Auffray JL, Juthier F, Schurtz G, Lemesle G, Caspar T, Morel O, Dumonteil N, Duhamel A, Paris C, Dupont-Prado A, Legendre P, Mouquet F, Marchant B, Hermoire S, Corseaux D, Moussa K, Manchuelle A, Bauchart JJ, Loobuyck V, Caron C, Zawadzki C, Leroy F, Bodart JC, Staels B, Goudemand J, Lenting PJ, Susen S. Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2016 Jul 28;375(4):335-44. doi: 10.1056/NEJMoa1505643.