Aortic Stenosis, Heart Failure
Conditions
Keywords
Acquired Von Willebrand, Trans aortic valve replacement, mechanical circulatory support
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
Interventions
DEVICEcardiac devices
patients receiving mechanical circulatory support or undergoing trans aortic valve replacement
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
STUDY_CHAIRSophie Susen, MD, PhD
University Hospital, Lille
Outcome results
None listed