Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis

Официальное название

Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis: the Multicenter LOW-TAVR Registry

Обзор

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) and, in particular: * risk factors * gender differences * comorbidities * pharmacological treatment * TAVR procedural characteristics * periprocedural and in-hospital complications * clinical outcome at 30-day, 1-year, 2-year and 5-year follow-up

Подробное описание

LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR).

The register aims to include at least 1350 patients diagnosed with LFLG-AS undergoing TAVR at the participating centres.

The inclusion criteria are:

* LFLG-AS diagnosis according to current European Society of Cardiology guidelines * Age 18 years or older * Written informed consent

The exclusion criteria are:

* LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis * LFLG-AS referred for medical treatment or undergoing surgery

Clinical outcome is evaluated at a 30-day, 1-year, 2-year, and 5-year follow-up.

The primary endpoint of interest of the registry is the assessment of the incidence of the composite of all-cause mortality and hospitalization for heart failure at one year.

The secondary endpoints are the assessment of:

* periprocedural TAVR complications: complete atrioventricular block, stroke, acute myocardial infarction, acute aortic insufficiency, cardiogenic shock, acute pulmonary edema, cardiac tamponade, aortic rupture; * adverse events during hospitalization: major and minor bleeding, major and minor vascular complications, definitive pacemaker implantation, cardiogenic shock, myocardial infarction, stroke, and death; * adverse events at 30 days, one year, two years, and five years: all-cause mortality, hospitalizations for heart failure, cardiovascular mortality, myocardial infarction, stroke, major and minor bleedings.

Вмешательства

• Устройство Transcatheter aortic valve replacement
  Transcatheter aortic valve replacement with implantation of new-generation balloon-expandable or self-expandable bioprostheses

Первичные конечные точки

• Composite of all-cause death and hospitalization for worsening heart failure [Срок оценки: 1 year]

Критерии участия

Критерии включения

• LFLG-AS diagnosis according to current European Society of Cardiology guidelines
• Age 18 years or older
• Written informed consent

Критерии исключения

• LFLG-AS pseudo-severe or non-confirmed severe aortic stenosis
• LFLG-AS referred for medical treatment or undergoing surgery

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• University of Salerno — Salerno

Публикации

• Ferruzzi GJ, Bellino M, Silverio A, Saia F, Bruno AG, Boragine P, Buono A, De Rosa ML, Cancro FP, Porto I, Crimi G, Calabro P, Moscarella E, Ielasi A, Montonati C, De Carlo M, Sticchi A, Lanni F, Di Muro FM, Maiellaro F, Calchera IF, Boccuzzi G, Sorropago A, Scudiero F, Attisano T, Citro R, Granata G, De Luca G, Musumeci G, Galasso G; LOW-TAVR Investigators. Balloon-Expandable Versus Self-Expandin PMID 42132173

Идентификаторы

NCT: NCT06589063 · 13202409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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