Von Willebrand Factor Point-of-care Testing to Improve Minimally Invasive TAVI Outcomes

Официальное название

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

Обзор

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).

Вмешательства

• Диагностический тест 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.
• Другое 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.

Первичные конечные точки

• composite 1-year event rate of [Срок оценки: At 1 year]

Вторичные конечные точки (12)

• All-cause death rate [Срок оценки: At 30 days, at 1 year]
• PVR rate [Срок оценки: At 30 days, at 1 year]
• Rehospitalization for heart failure rate [Срок оценки: At 30 days, at 1 year]
• Delayed valve re-intervention rate [Срок оценки: At 1 year]
• Delayed valve re-intervention rate [Срок оценки: At 30 days, at 1 year]
• Mean transaortic gradient >20mmHg rate [Срок оценки: At 30 days]
• composite event rate [Срок оценки: At 30 days]
• composite event rate of the following individual safety endpoints [Срок оценки: at 24hours]
• Aortic injury rate [Срок оценки: at 24hours]
• Coronary artery occlusion rate [Срок оценки: at 24hours]
• Tamponade rate [Срок оценки: at 24hours]
• All stroke (transient or definite) rate [Срок оценки: at 24hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 9 центров

• 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
• … и ещё 1 центр

Идентификаторы

NCT: NCT03728049 · 2017_77 · 2018-A01175-50 · PHRC-17-0697

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗