Myocardial work in severe aortic stenosis

Not Applicable

• Conditions: Severe aortic stenosis prior to transcatheter aortic valve intervention; Circulatory System

• Registration Number: ISRCTN87182483
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-12
• Last Update Posted: 16 January 2023
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 140

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

1. Age under 18 years old
2. Mild or moderate aortic stenosis (<4.0m/s), mean gradient (<40mmHg), and aortic valve area >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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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.<br>