Heart FailureWiTAViNCT02628509
Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure
An observational study of Heart Failure and Aortic Stenosis, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Aortic Stenosis
- What is being tested?
- cardiac devices
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2012to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients receiving mechanical circulatory support or undergoing aortic valve replacement
Who may be able to join
- 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)
Who cannot join
- Patient with a known severe bleeding disorder
- Patient refusal or environment
- Minor patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow
The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.
Read the 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
- Conditions
- Heart Failure, Aortic Stenosis
- Being tested
- cardiac devices
- Keywords
- Acquired Von Willebrand, Trans aortic valve replacement, mechanical circulatory support
- Medical subject headings
- Heart Failure, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac devicesDevice
Also called trans aortic valve replacement, mechanical circulatory support
patients receiving mechanical circulatory support or undergoing trans aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| cardiac devices | patients receiving mechanical circulatory support patients undergoing transaortic valve replacement Receives: Device: cardiac devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 180 minutes after device implantation
Secondary outcomes (1)
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.
Measured: 5, 15,30, 60 minutes; day 1 , day 7 after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start1 Aug 2012
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Susen, MD, PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628509
- Sponsor's protocol ID
- NI_59
- Acronym
- WiTAVi
- Status last verified
- May 2026
- First submitted
- 9 Dec 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25670067Vincent 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.
PubMed 32172643Van 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.
PubMed 27464202
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow
- ClinicalTrials.gov ID
- NCT02628509
- Acronym / sponsor ID
- WiTAVi / NI_59
- Conditions
- Heart Failure, Aortic Stenosis
- Keywords
- Acquired Von Willebrand, Trans aortic valve replacement, mechanical circulatory support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac devices | – | Device: cardiac devicespatients receiving mechanical circulatory support patients undergoing transaortic valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving mechanical circulatory support or undergoing aortic valve replacement
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- Patient with a known severe bleeding disorder
- Patient refusal or environment
- Minor patients
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac devicesAlso: trans aortic valve replacement, mechanical circulatory supportpatients receiving mechanical circulatory support or undergoing trans aortic valve replacement | Device | cardiac devices |
Primary outcome
Von Willebrand factor (VWF) multimer defects
Time frame: 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).
1 secondary outcome
platelet function analyser- ADP (PFA-ADP) closure time
Time frame: 5, 15,30, 60 minutes; day 1 , day 7 after device implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 25670067Van 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.
- Derived from this study: PubMed 32172643Vincent 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.
- Derived from this study: PubMed 27464202Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Susen, MD, PhD study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Aortic Stenosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Von Willebrand factor (VWF) multimer defects (time frame: 180 minutes after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02628509, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.