Aortic Valve Insufficiency, Aortic Valve Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, Paravalvular regurgitation, Point-of-care test, Biomarker, Aortic stenosis, Von willebrand Factor
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).
Interventions
DIAGNOSTIC_TESTCT-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.
OTHERNo 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.
Sponsors
University Hospital, Lille
Siemens Healthineers, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter open-label randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| composite 1-year event rate of | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death rate | At 30 days, at 1 year | All-cause death |
| PVR rate | At 30 days, at 1 year | PVR superior or egal to moderate |
| Rehospitalization for heart failure rate | At 30 days, at 1 year | Rehospitalization for heart failure |
| Delayed valve re-intervention rate | At 1 year | Delayed valve re-intervention |
| Mean transaortic gradient >20mmHg rate | At 30 days | Mean transaortic gradient \>20mmHg |
| composite event rate | At 30 days | 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 |
| composite event rate of the following individual safety endpoints | at 24hours | Aortic injury; Coronary artery occlusion; Tamponade; All stroke (transient or definite) |
| Aortic injury rate | at 24hours | Aortic injury |
| Coronary artery occlusion rate | at 24hours | Coronary artery occlusion |
| Tamponade rate | at 24hours | Tamponade |
| All stroke (transient or definite) rate | at 24hours | All stroke (transient or definite) |
Countries
France
Contacts
CONTACTEric Van Belle, MD,PhD
CONTACTFlavien Vincent, MD, PhD
PRINCIPAL_INVESTIGATOREric Vanbelle, MD, PhD
University Hospital, Lille
Outcome results
None listed