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

Sponsor
Imperial College Healthcare NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04915976
Collaborator
(none)
14,086
Enrollment
168
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    14086 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Gender-specific Temporal Trends in Survival in Patients With Severe Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
    Actual Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality [3 years]

      Death

    2. Cardiovascular Mortality [3 years]

      cardiac death

    Secondary Outcome Measures

    1. Major adverse cardiovascular events [3 years]

      myocardial infarction, stroke, heart failure hospitalisations

    2. Bleeding (according to BARC - life threatening, major, minor) [3 years]

      BARC classification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    All comers - retrospective registry

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Imperial College Healthcare NHS Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Mikhail, Consultant Cardiologist, Imperial College Healthcare NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04915976
    Other Study ID Numbers:
    • 283163
    First Posted:
    Jun 7, 2021
    Last Update Posted:
    Jun 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ghada Mikhail, Consultant Cardiologist, Imperial College Healthcare NHS Trust
    aortic stenosis, TAVR, TAVI, Transcatheter aortic valve implantation, Gender differences
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Jun 7, 2021