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临床试验/NCT04915976
NCT04915976暂停不适用

Gender-specific Temporal Trends in Survival in Patients With Severe Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

Imperial College Healthcare NHS Trust0 个研究点目标入组 14,086 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
14,086
主要终点
All cause mortality

研究概览

简要总结

Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over conventional aortic surgery. Several studies have shown that females have an apparent better outcome with TAVI than males.

There are a number of possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling.

We aim to explore the long term outcomes of TAVI between males and females to try and identify specific tailored treatment options.

This data will be useful in providing important information regarding gender differences in patients who are treated with transcatheter aortic valve implantation. Data provided will include long term outcomes and predictors of outcome.

The study team will then identify and implement strategies to improve outcomes in patients being treated with transcatheter aortic valve implantation.

详细描述

Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and accounts for more than 40% of patients with native valvular disease with an approximately equal prevalence in males and females.

Transcatheter aortic valve implantation (TAVI) is now widely practiced with treatment of over 300,000 patients worldwide. Many centres now regularly implant devices in patients for whom conventional aortic valve replacement (AVR) is deemed high or intermediate risk. Several studies have shown that females have an apparent better outcome with TAVI than males.

There are numerous possible reasons as to the apparent favourable benefit of TAVI in women including: having both lower rates of moderate / severe aortic regurgitation and peri-procedural mortality, lower rates of bleeding and renal failure, better patient prosthesis match and recovery of left ventricular function with more favourable left ventricular remodelling.

Rationale for proposal:

Newer devices have reduced the introducer French size and are hence associated with reduced rates of vascular and bleeding complications. This may translate to an even higher survival benefit in female versus male patients with severe aortic stenosis treated with transfemoral TAVI. In the current study we will aim to investigate gender temporal survival trends, and complications including stroke and heart attack in aortic stenosis patients treated with current versus older generation transcatheter valves. We have already been successful in obtaining the periprocedural data from NICOR and and mortality data will be linked from NHS digital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

All cause mortality

时间窗: 3 years

Death

Cardiovascular Mortality

时间窗: 3 years

cardiac death

次要结局

  • Major adverse cardiovascular events(3 years)
  • Bleeding (according to BARC - life threatening, major, minor)(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Mikhail

Consultant Cardiologist

Imperial College Healthcare NHS Trust

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