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

Heart Failure Clinical Trial

— WiTAVi  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02628509
• Other study ID #: NI_59
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2015
• Last updated: February 8, 2017
• Start date: August 2012
• Est. completion date: January 2018

Study information

• Verified date: February 2017
• Source: University Hospital, Lille
• Contact: Sophie Susen, MD, PhD
• Phone: 33320445937
• Email: sophie.susen[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Heart Failure

Intervention

Device:
• cardiac devices
patients receiving mechanical circulatory support or undergoing trans aortic valve replacement

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Von Willebrand factor (VWF) multimer defects	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).	180 minutes after device implantation
Secondary	platelet function analyser- ADP (PFA-ADP) closure time	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.	5, 15,30, 60 minutes; day 1 , day 7 after device implantation