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). (PAVI_TAVI)
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).
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.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Marco Ferlini, MD
- 电话号码：+390382503158
- 邮箱：m.ferlini@smatteo.pv.it
研究联系人备份
- 姓名：Alessia Currao, PM
- 电话号码：+39 0382503739
- 邮箱：a.currao@smatteo.pv.it
学习地点
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Pavia
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Pavia、Pavia、意大利、27100
- 招聘中
- Fondazione IRCCS Policlinico San Matteo
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接触：
- Marco Ferlini, MD
- 电话号码：+39 0382503158
- 邮箱：m.ferlini@smatteo.pv.it
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Age > 18 years.
- Transcatheter treatment with a bioprosthesis on native aortic valve, on degenerated aortic bioprosthesis, or on degenerated mitral prostheses/rings.
Exclusion Criteria:
- Failure to sign the informed consent.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Not applicable, as this is a registry tracking all TAVI procedures performed at IRCCS Policlinico Sa
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
5-years all cause death
大体时间：5 years
|
All-cause mortality at 5-year follow-up from the index procedure
|
5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of in-hospital adverse events (VARC-2 criteria)
大体时间：5 years
|
Number of in-hospital adverse events (VARC-2 criteria)
|
5 years
|
|
Number of patients with bioprosthetic valve dysfunction
大体时间：5 years
|
Number of patients with bioprosthetic valve dysfunction
|
5 years
|
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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).
大体时间：5 years
|
5 years
|
|
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HF Hospitalization rate
大体时间：5 years
|
HF Hospitalization rate
|
5 years
|
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Acute Myocardial Infarction (AMI)
大体时间：5 years
|
any type of AMI (STEMI, ST-Elevation Myocardial Infarction; NSTEMI, Non-ST-Elevation Myocardial Infarction; silent AMIs)
|
5 years
|
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Stroke/TIA
大体时间：5 years
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Stroke/TIA
|
5 years
|
|
MACE
大体时间：5 years
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MACE (CV death, AMI, stroke/TIA, revascularization, UA)
|
5 years
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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