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

NCT02628509 | Unknown

• 1 other identifier: NI_59
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Aortic Stenosis

Keywords

Acquired Von Willebrand; Trans aortic valve replacement; mechanical circulatory support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Study Arms (1)

cardiac devices

patients receiving mechanical circulatory support patients undergoing transaortic valve replacement

Device: cardiac devices

Interventions

cardiac devices DEVICE

patients receiving mechanical circulatory support or undergoing trans aortic valve replacement

Also known as: trans aortic valve replacement, mechanical circulatory support

cardiac devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients receiving mechanical circulatory support or undergoing aortic valve replacement

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Lille University Hospital

Lille, 59037, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 25670067 BACKGROUND

• 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.

  PMID: 32172643 DERIVED

• 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.

  PMID: 27464202 DERIVED

MeSH Terms

Conditions

Heart Failure; Aortic Valve Stenosis

Interventions

Cardiac Resynchronization Therapy Devices

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Pacemaker, Artificial; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Sophie Susen, MD, PhD

  Lille University Hospital

  STUDY CHAIR

Central Study Contacts

Sophie Susen, MD, PhD

CONTACT

33320445937; sophie.susen@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 11, 2015
• Study Start: August 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)