Aortic Valve StenosisWITAVI-REALNCT03728049
Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
A study testing CT-ADP performed during TAVI procedure and No CT-ADP performed during TAVI procedure in people with Aortic Valve Stenosis and Aortic Valve Insufficiency, run by University Hospital, Lille at 9 sites in France.
Trial summary
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- What is being tested?
- CT-ADP performed during TAVI procedure and No CT-ADP performed during TAVI procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 944 participants
- Where
- 9 sitesFrance
- Study dates
- 18 Dec 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.
- Symptomatic aortic stenosis scheduled to undergo TAVI
- TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
- All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted
Who cannot join
- TAVI through non-transfemoral approach
- TAVI with concomitant percutaneous coronary intervention
- TAVI performed under general anesthesia
- TAVI performed under TEE guidance
- Valve-in-valve procedure
- Inability to provide informed consent
- Associated ≥ moderate mitral regurgitation
- Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand
- Recruiting
Institut Coeur-Poumon, CHU
Lille, 59037
0320445962
Eric VAN BELLE, MD,PhD
- Not yet recruiting
Chu Montpellier
Montpellier
- Not yet recruiting
CHU de Nimes
Nîmes
- Not yet recruiting
Hu Pitie Salpetriere Aphp - Paris 13
Paris
- Recruiting
Hopital Haut-Leveque - Chu - Pessac
Pessac, 33604
- Not yet recruiting
Chru Rennes Site Pontchaillou
Rennes
- Not yet recruiting
Hopital Civil / Nouvel Hopital Civil - Strasbourg
Strasbourg
- Recruiting
CHU de Toulouse
Toulouse
About this study
Official title: Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.
The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Being tested
- CT-ADP performed during TAVI procedure, No CT-ADP performed during TAVI procedure
- Keywords
- Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-ADP performed during TAVI procedureDiagnostic test
The CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment.
No CT-ADP performed during TAVI procedureOther
PVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator.
| Study group | Role | What they receive |
|---|---|---|
| CT-ADP group | Experimental | PVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment. Receives: Diagnostic Test: CT-ADP performed during TAVI procedure |
| Control group | Other | PVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the standard methods of PVR assessment. Receives: Other: No CT-ADP performed during TAVI procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite 1-year event rate of
rate of All-cause death; rate of Paravalvular regurgitation ≥ moderate; rate of Rehospitalization; rate of Stroke; rate of Delayed valve re-intervention; rate of Mean transaortic gradient >20mmHg.
Measured: At 1 year
Secondary outcomes (12)
All-cause death rate
All-cause death
Measured: At 30 days, at 1 year
PVR rate
PVR superior or egal to moderate
Measured: At 30 days, at 1 year
Rehospitalization for heart failure rate
Rehospitalization for heart failure
Measured: At 30 days, at 1 year
Delayed valve re-intervention rate
Delayed valve re-intervention
Measured: At 1 year
Delayed valve re-intervention rate
Delayed valve re-intervention
Measured: At 30 days, at 1 year
Mean transaortic gradient >20mmHg rate
Mean transaortic gradient >20mmHg
Measured: At 30 days
composite event rate
All-cause death; PVR superior or egal to moderate; Rehospitalization for heart failure; All stroke (transient or definite); Delayed valve re-intervention; Mean transaortic gradient >20mmHg
Measured: At 30 days
composite event rate of the following individual safety endpoints
Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite)
Measured: at 24hours
Aortic injury rate
Aortic injury
Measured: at 24hours
Coronary artery occlusion rate
Coronary artery occlusion
Measured: at 24hours
Tamponade rate
Tamponade
Measured: at 24hours
All stroke (transient or definite) rate
All stroke (transient or definite)
Measured: at 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start18 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter open-label randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthineers
- Responsible party
- Sponsor
- Investigators
- Eric Vanbelle, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728049
- Sponsor's protocol ID
- 2017_77
- Other IDs
- 2018-A01175-50, PHRC-17-0697
- Acronym
- WITAVI-REAL
- Status last verified
- May 2026
- First submitted
- 30 Oct 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI
- ClinicalTrials.gov ID
- NCT03728049
- Acronym / sponsor ID
- WITAVI-REAL / 2017_77
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Keywords
- Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 944 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Siemens Healthineers
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Nov 2018 (actual)
- 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.
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.
The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter open-label randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| CT-ADP group | Experimental | Diagnostic Test: CT-ADP performed during TAVI procedurePVR assessment with the standard methods and with the CT-ADP that will be provided to the operator in real-time during TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator and based on the results of the CT-ADP on top of the standard methods of PVR assessment. |
| Control group | Other | Other: No CT-ADP performed during TAVI procedurePVR assessment with standard methods only (at discretion of the operator excluding CT-ADP and transesophageal echocardiography). CT-ADP will not be provided to the operator at the time of TAVI. The decision to undertake corrective procedure will be left at the discretion of the operator according to the results of the standard methods of PVR assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team.
- Symptomatic aortic stenosis scheduled to undergo TAVI
- TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance.
- All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted
Key exclusion criteria (8 listed)
- TAVI through non-transfemoral approach
- TAVI with concomitant percutaneous coronary intervention
- TAVI performed under general anesthesia
- TAVI performed under TEE guidance
- Valve-in-valve procedure
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 |
|---|---|---|
| CT-ADP performed during TAVI procedureThe CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment. | Diagnostic test | CT-ADP group |
| No CT-ADP performed during TAVI procedurePVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator. | Other | Control group |
Primary outcome
composite 1-year event rate of
Time frame: At 1 year
rate of All-cause death; rate of Paravalvular regurgitation ≥ moderate; rate of Rehospitalization; rate of Stroke; rate of Delayed valve re-intervention; rate of Mean transaortic gradient >20mmHg.
12 secondary outcomes
All-cause death rate
Time frame: At 30 days, at 1 year
PVR rate
Time frame: At 30 days, at 1 year
Rehospitalization for heart failure rate
Time frame: At 30 days, at 1 year
Delayed valve re-intervention rate
Time frame: At 1 year
Delayed valve re-intervention rate
Time frame: At 30 days, at 1 year
Mean transaortic gradient >20mmHg rate
Time frame: At 30 days
composite event rate
Time frame: At 30 days
composite event rate of the following individual safety endpoints
Time frame: at 24hours
Aortic injury rate
Time frame: at 24hours
Coronary artery occlusion rate
Time frame: at 24hours
Tamponade rate
Time frame: at 24hours
All stroke (transient or definite) rate
Time frame: at 24hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Eric Vanbelle, MD, PhD principal investigator
University Hospital, Lille
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-ADP performed during TAVI procedure and No CT-ADP performed during TAVI procedure in people with Aortic Valve Stenosis and Aortic Valve Insufficiency, run by University Hospital, Lille at 9 sites 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 4 inclusion and 8 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: looking for participants now, 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 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Van Belle, MD,PhD (03 20 44 50 15 ext. +33, eric.vanbelle2@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite 1-year event rate of (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.