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
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.
- 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