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

NCT ID: NCT02628509

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-01-31

Brief Summary

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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

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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

Conditions

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Heart Failure Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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cardiac devices

patients receiving mechanical circulatory support patients undergoing transaortic valve replacement

cardiac devices

Intervention Type DEVICE

patients receiving mechanical circulatory support or undergoing trans aortic valve replacement

Interventions

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cardiac devices

patients receiving mechanical circulatory support or undergoing trans aortic valve replacement

Intervention Type DEVICE

Other Intervention Names

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trans aortic valve replacement mechanical circulatory support

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie Susen, MD, PhD

Role: STUDY_CHAIR

Lille University Hospital

Locations

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Lille University Hospital

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Susen, MD, PhD

Role: CONTACT

33320445937

Facility Contacts

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Sophie Susen, MD,PhD

Role: primary

33320445937

References

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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.

Reference Type BACKGROUND
PMID: 25670067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32172643 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27464202 (View on PubMed)

Other Identifiers

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NI_59

Identifier Type: -

Identifier Source: org_study_id

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