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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04915976
Other study ID # 283163
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date January 2007
Est. completion date January 2025

Study information

Verified date December 2023
Source Imperial College Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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. Objectives The current study will aim to: 1. Compare the mid-long term survival of females versus males in patients with AS treated with current versus older TAVI technologies. Study design In the current study, all patients undergoing transfemoral TAVI in the UK (between 2007 and 2017) will be included.


Recruitment information / eligibility

Status Suspended
Enrollment 14086
Est. completion date January 2025
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility All comers - retrospective registry

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Imperial College Healthcare NHS Trust

Outcome

Type Measure Description Time frame Safety issue
Primary All cause mortality Death 3 years
Primary Cardiovascular Mortality cardiac death 3 years
Secondary Major adverse cardiovascular events myocardial infarction, stroke, heart failure hospitalisations 3 years
Secondary Bleeding (according to BARC - life threatening, major, minor) BARC classification 3 years
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