Clinical trial NCT03728049: Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Aortic Valve Insufficiency
Keywords: Transcatheter Aortic Valve Replacement
Paravalvular regurgitation
Point-of-care test
Biomarker
Aortic stenosis
Von willebrand Factor
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Siemens Healthineers, France
name: Ministry of Health, France
First posted: 2018-11-01
Enrollment: 944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter open-label randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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 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).


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

Primary outcomes:
measure: composite 1-year event rate of
timeFrame: At 1 year
Secondary outcomes:
measure: All-cause death rate
timeFrame: At 30 days, at 1 year
measure: PVR rate
timeFrame: At 30 days, at 1 year
measure: Rehospitalization for heart failure rate
timeFrame: At 30 days, at 1 year
measure: Delayed valve re-intervention rate
timeFrame: At 1 year
measure: Delayed valve re-intervention rate
timeFrame: At 30 days, at 1 year
measure: Mean transaortic gradient >20mmHg rate
timeFrame: At 30 days
measure: composite event rate
timeFrame: At 30 days
measure: composite event rate of the following individual safety endpoints
timeFrame: at 24hours
measure: Aortic injury rate
timeFrame: at 24hours
measure: Coronary artery occlusion rate
timeFrame: at 24hours
measure: Tamponade rate
timeFrame: at 24hours
measure: All stroke (transient or definite) rate
timeFrame: at 24hours
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Hopital Estaing - Chu63 - Clermont Ferrand
city: Lille
country: France
facility: Institut Coeur-Poumon, CHU
city: Montpellier
country: France
facility: Chu Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Hu Pitie Salpetriere Aphp - Paris 13
city: Pessac
country: France
facility: Hopital Haut-Leveque - Chu - Pessac
city: Rennes
country: France
facility: Chru Rennes Site Pontchaillou
city: Strasbourg
country: France
facility: Hopital Civil / Nouvel Hopital Civil - Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Lille
name: Eric Vanbelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: