Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-ADP performed during TAVI procedure, No CT-ADP performed during TAVI procedure.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis, Aortic Valve Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Diagnostic test CT-ADP performed during TAVI procedure
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. - Other No CT-ADP performed during TAVI procedure
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.
Primary outcome measures
- composite 1-year event rate of [Time frame: At 1 year]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 9 centers
- Hopital Estaing - Chu63 - Clermont Ferrand — Clermont-Ferrand
- Institut Coeur-Poumon, CHU — Lille
- Chu Montpellier — Montpellier
- CHU de Nimes — Nîmes
- Hu Pitie Salpetriere Aphp - Paris 13 — Paris
- Hopital Haut-Leveque - Chu - Pessac — Pessac
- Chru Rennes Site Pontchaillou — Rennes
- Hopital Civil / Nouvel Hopital Civil - Strasbourg — Strasbourg
- … and 1 more center
Identifiers
NCT: NCT03728049 · 2017_77 · 2018-A01175-50 · PHRC-17-0697