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

• Conditions: Heart Failure; Aortic Stenosis
• Interventions: Device: cardiac devices

• Registration Number: NCT02628509
• Lead Sponsor: University Hospital, Lille

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac devices	cardiac devices	patients receiving mechanical circulatory support patients undergoing transaortic valve replacement

Primary Outcome Measures

Name	Time	Method
Von Willebrand factor (VWF) multimer defects	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 Outcome Measures

Name	Time	Method
platelet function analyser- ADP (PFA-ADP) closure time	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.

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France