Идёт набор NCT07596394

A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy).

— Наблюдательное Severe Aortic Stenosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo.
Кому может быть актуально: Состояния в реестре: Severe Aortic Stenosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective and Retrospective Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (PAVI_TAVI Registry).

Обзор

PAVI-TAVI Registry Overview The PAVI-TAVI Registry is an observational study at Fondazione IRCCS Policlinico San Matteo in Pavia, Italy. It tracks real-world outcomes of transcatheter heart valve procedures like TAVI (for aortic stenosis), valve-in-valve (VIV), TAVI for aortic insufficiency (TAVI-IAo), and TMVR (for degenerated mitral valves) in patients over 18 years old. Who Can Join Eligible patients include adults treated with these procedures on native aortic valves, failed aortic bioprostheses, or degenerated mitral prostheses/rings. The only exclusion is not providing informed consent. Study Goals The main goal is to evaluate TAVI's safety and effectiveness over 5 years, focusing on all-cause mortality from the initial procedure. Secondary goals assess complication rates, valve function, inflammation markers, heart failure hospitalizations, heart attacks, strokes, and major cardiac events. How It Works No experimental treatments-it's a registry collecting routine clinical data via a secure electronic system. Follow-up happens at your doctor's discretion, ideally at 3 and 12 months, then yearly (often by phone for stable cases). The study aims to enroll 500+ patients.

Вмешательства

Устройство Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico San Matteo

Первичные конечные точки

5-years all cause death [Срок оценки: 5 years]

Вторичные конечные точки (7)

Number of in-hospital adverse events (VARC-2 criteria) [Срок оценки: 5 years]
Number of patients with bioprosthetic valve dysfunction [Срок оценки: 5 years]
Assessment of pre- and post-procedural inflammatory indices (neutrophil-to-lymphocyte ratio and uric acid), if available, in TAVI-treated patients and correlation with clinical outcomes and prosthesis degeneration (SVD). [Срок оценки: 5 years]
HF Hospitalization rate [Срок оценки: 5 years]
Acute Myocardial Infarction (AMI) [Срок оценки: 5 years]
Stroke/TIA [Срок оценки: 5 years]
MACE [Срок оценки: 5 years]

Критерии участия

Критерии включения

Age > 18 years.
Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.