Surgery Clinical Trial
Official title:
Gender-specific Temporal Trends in Survival in Patients With Severe Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
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 |
Verified date | December 2023 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust |
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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