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Myocardial work in severe aortic stenosis

Can the use of echocardiographic derived myocardial work predict outcomes in patients with severe aortic stenosis prior to transcatheter aortic valve intervention

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN87182483
Enrollment
140
Registered
2022-12-12
Start date
2022-11-30
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Severe aortic stenosis prior to transcatheter aortic valve intervention Circulatory System

Interventions

A standard transthoracic echocardiogram and non-invasive blood pressure will be performed prior to transcatheter aortic valve intervention (TAVI) to assess myocardial work. This is a non-randomised, s

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severe aortic stenosis with a peak velocity (>4.0m/s), mean gradient (>40mmHg) and an aortic valve area <1.0cm on transthoracic echocardiography requiring a transcatheter aortic valve intervention. 2. Patients with low-flow aortic stenosis (peak gradient <4.0m/s with AVA <1.0cm2) who require a TAVI will also be invited to participate

Exclusion criteria

Exclusion criteria: 1. Age under 18 years old 2. Mild or moderate aortic stenosis (1.0cm 3. Suboptimal image quality which does not allow for quantitative left ventricular function assessment by Biplane Simpson, myocardial deformation imaging and myocardial work 4. Poorly controlled arrhythmias or more than moderate mitral regurgitation 5. Unable to tolerate a transthoracic echocardiogram 6. Do not provide consent

Design outcomes

Primary

MeasureTime frame
1. Myocardial work measured using echocardiography assessed immediately before transcatheter aortic valve intervention (TAVI), immediately post-TAVI, and at 6 weeks and 12 months post-procedure. 2. Survival and incidence of major adverse clinical endpoints measured by contacting patients by telephone, post or email at 6 monthly intervals up to 3 years, and by echocardiograms performed at 6 weeks and 12 months. Mortality will be reviewed by assessing patient medical records prior to contacting patients at six-month intervals.

Secondary

MeasureTime frame
1. Myocardial work results in seated and supine patients measured using non-invasive blood pressure and echocardiography prior to and post TAVI (before hospital discharge), 6 weeks and 12 months post-TAVI 2. Post-procedure Myocardial work results in patients with differing valve types measured using echocardiography. Evaluating percentage change in myocardial work in severe aortic stenosis patients before the valve implantation and compare to myocardial work following the TAVI using echocardiography to see if percentage change predicts mortality and hospitalisation at end of study follow-up at 3 years.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026