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TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.

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

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04915976
Enrollment
14086
Registered
2021-06-07
Start date
2007-01-31
Completion date
2025-01-31
Last updated
2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Gender, Surgery

Keywords

aortic stenosis, TAVR, TAVI, Transcatheter aortic valve implantation, Gender differences

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Imperial College Healthcare NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All comers - retrospective registry

Design outcomes

Primary

MeasureTime frameDescription
All cause mortality3 yearsDeath
Cardiovascular Mortality3 yearscardiac death

Secondary

MeasureTime frameDescription
Major adverse cardiovascular events3 yearsmyocardial infarction, stroke, heart failure hospitalisations
Bleeding (according to BARC - life threatening, major, minor)3 yearsBARC classification

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026