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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04204915
Registration number
NCT04204915
Ethics application status
Date submitted
17/12/2019
Date registered
19/12/2019
Date last updated
21/09/2023
Titles & IDs
Public title
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
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Scientific title
A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis
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Secondary ID [1]
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CS/18/7/33714
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Secondary ID [2]
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0700
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Universal Trial Number (UTN)
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Trial acronym
EASY-AS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Aortic valve replacement
Active Comparator: Group A: Aortic valve replacement - Participants randomised to AVR will be investigated and managed according to local protocols and standard practice. Participants will be placed on the waiting list with the aim that surgery will be performed within 3 months, dependent on local hospitals' waiting lists.
No Intervention: Group B: Expectant management - Participants randomised to expectant management will continue to have regular monitoring of their condition in line with the procedures and standard practices of their hospital.
Treatment: Surgery: Aortic valve replacement
Participants will be assessed by a member of the surgical team performing aortic valve replacement (AVR), and by any other relevant medical professionals identified by the doctors overseeing their care in hospital. When deemed ready for AVR, a member of the surgical team will ask for consent to proceed with the AVR. They will discuss the surgical procedure, covering information on the basic technical procedure, risks and expected recovery time.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combined measure of cardiovascular death and hospitalisation for heart failure
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Assessment method [1]
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Measured in days from randomisation until end of trial (minimum 3 years).
The primary analysis will be undertaken when 663 events have accrued, which is estimated to be after a median of 5 years follow-up assuming 2844 patients are recruited over 4 years.
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Timepoint [1]
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Minimum 3 years
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Secondary outcome [1]
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WHO Disability Assessment Schedule (WHODAS 2.0)
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Assessment method [1]
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Assessing disability-free survival during the period of active recruitment.
Scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. The simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.
Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
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Timepoint [1]
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6, 12, 24 and 36 months
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Secondary outcome [2]
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NHS record linkage services
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Assessment method [2]
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Assessing number of days alive and out of hospital.
All participants will be consented for long-term follow-up (10 years) and clinical events will be ascertained through NHS Digital or equivalent.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Death (cardiovascular, including sudden cardiac death, and non-cardiovascular), hospitalisation for heart failure, myocardial infarction, stroke
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Assessment method [3]
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Assessing number of major adverse events.
All participants will be consented for long-term follow-up (10 years) and clinical events will be ascertained through NHS Digital or equivalent.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Number of additional outcomes of special interest: infective endocarditis and major bleeding, resuscitated cardiac arrest, hospitalisation with new onset atrial fibrillation, syncope, revascularization (CABG/PCI), cardiac device implantation
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Assessment method [4]
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Assessing additional outcomes of special interest.
All participants will be consented for long-term follow-up (10 years) and clinical events will be ascertained through NHS Digital or equivalent.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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EuroQol five-level (EQ-5D-5L) questionnaire
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Assessment method [5]
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Assessing quality of life during the period of active recruitment.
EQ-5D-5L has 2 components: health state description and evaluation. In the description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a 5-level scale.
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Timepoint [5]
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6, 12, 24 and 36 months
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Secondary outcome [6]
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Health Economics Questionnaire
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Assessment method [6]
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Assessed using self-reported health care resource use and cost effectiveness.
Participants will be asked if they have used any of the following services at a hospital for reasons that may be related to their heart condition or treatment: hospital services, services in the community and specialist equipment.
The data from this questionnaire will be scored by a Health Economist at the end of the study.
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Timepoint [6]
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6, 12, 24 and 36 months
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Secondary outcome [7]
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Edmonton Frail Scale (EFS) (Bedside and Acute Care Version)
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Assessment method [7]
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Assessing frailty at baseline using a simple tool to assess frailty in older patients. It consists of nine domains and eleven items, each scoring 0 points (frailty absent or normal health), 1 point (minor errors or mild/moderate impairment), or 2 points (important errors or severely impaired).
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Timepoint [7]
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Baseline
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Eligibility
Key inclusion criteria
1. Age >18 years
2. Patient has severe asymptomatic AS, in line with current international guidelines,
defined as either:
1. Peak velocity =4m/s OR mean pressure gradient =40mmHg WITH aortic valve area
=1.0cm2 OR =0.6cm2/m2 body surface area OR
2. Peak velocity =4m/s OR mean pressure gradient =40mmHg WITH aortic valve area >1.0
- =1.2cm2 OR >0.6 - =0.7cm2/m2 body surface area AND high sex specific calcium
score* OR
3. Peak Velocity =3.5m/s - 3.9m/s AND mean pressure gradient <40 mmHg WITH aortic
valve area =1.0cm2 OR =0.6cm2/m2 body surface area AND high sex specific calcium
score* *Sex specific high calcium scores (Agatston units): >1200 females; >2000
males
3. The responsible clinician feels that either ongoing surveillance or early AVR are
appropriate.
4. Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with
an acceptable risk
5. Willing to provide informed consent and be randomised to early AVR or expectant
management
6. An ability to understand one of the written languages that the study has provided
written and visual materials in, or the availability of a translator to explain the
study documentation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
7. Symptoms related to AS
8. Additional severe valvular heart disease
9. Other cardiac surgery planned pre-randomisation (eg CABG)
10. Left ventricular systolic dysfunction (LVEF <50%)
11. Pregnancy
12. Co-morbid condition that, in the opinion of the treating cardiologist, limits life
expectancy to <2 years
13. Patient has previously undergone AVR or TAVI with restenosis
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2031
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Actual
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Sample size
Target
2844
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
CanberraNSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Liverpool Hospital - Liverpool
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Royal North Shore Hospital - St Leonards
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Westmead Hospital - Westmead
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Wollongong Hospital - Wollongong
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Prince Charles Hospital - Chermside
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Townsville Hospital - Douglas
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The Gold Coast Hospital - Southport
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Adelaide
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Monash Health - Clayton
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University Hospital Geelong - Geelong
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Fiona Stanley Hospital - Perth
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Royal Perth Hospital - Perth
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Lyell McEwin Hospital - Elizabeth Vale
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Northern Hospital - Epping
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Royal Hobart Hospital - Hobart
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Nepean Hospital - Kingswood
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Recruitment hospital [19]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [20]
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Royal Darwin Hospital - Tiwi
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2170 - Liverpool
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment postcode(s) [6]
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4032 - Chermside
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Recruitment postcode(s) [7]
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4814 - Douglas
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Recruitment postcode(s) [8]
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4215 - Southport
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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SA 5042 - Adelaide
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Recruitment postcode(s) [11]
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3168 - Clayton
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Recruitment postcode(s) [12]
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3220 - Geelong
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Recruitment postcode(s) [13]
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6150 - Perth
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Recruitment postcode(s) [14]
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WA6000 - Perth
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Recruitment postcode(s) [15]
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SA 5112 - Elizabeth Vale
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Recruitment postcode(s) [16]
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VIC 3076 - Epping
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Recruitment postcode(s) [17]
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TAS 7000 - Hobart
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Recruitment postcode(s) [18]
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NSW 2747 - Kingswood
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Recruitment postcode(s) [19]
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NSW 2305 - New Lambton Heights
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Recruitment postcode(s) [20]
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TIWI NT 0810 - Tiwi
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Recruitment outside Australia
Country [1]
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Dunedin
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Serbia
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Sremska Kamenica
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United Kingdom
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County Durham
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United Kingdom
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Denbighshire
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Dorset
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Hampshire
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Leicestershire
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Merseyside
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Norfolk
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North Lincolnshire
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Northamptonshire
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Northumberland
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Scotland
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Somerset
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Wales
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West Midlands
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Aberdeen
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Aintree
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Basildon
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Birmingham
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Blackpool
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Brighton
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Carlisle
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Darlington
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Doncaster
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Edinburgh
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Exeter
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Huddersfield
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Keighley
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Leeds
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Lincoln
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Liverpool
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London
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Maidstone
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Manchester
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Middlesbrough
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Plymouth
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Poole
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Portsmouth
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Southampton
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Stockton-on-Tees
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Torquay
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Warwick
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United Kingdom
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Yeovil
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Leicester
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Address
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Other collaborator category [1]
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Other
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Name [1]
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University Hospitals, Leicester
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Other collaborator category [2]
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Other
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Name [2]
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The University of Western Australia
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Other collaborator category [3]
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Other
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Name [3]
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University of Auckland, New Zealand
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Address [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
Aortic stenosis (AS) affects approximately 5% of individuals >65 years old, with ~3% of
people >75 years having moderate to severe disease. The prevalence of AS is rising rapidly
due to an ageing population and is projected to double in the next two decades. Increasingly
clinicians face the dilemma of how to best manage this growing population of mainly elderly
patients, many of whom are asymptomatic but have been identified as having severe AS, often
as an incidental finding. Reduced aortic valve opening progresses over decades without any
apparent symptoms because the heart compensates for the AS. Ultimately, compensatory
mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients
with severe AS remain untreated, they have a dire prognosis. In this situation the only
effective treatment is AVR, either surgically or using TAVI. Conversely, conventional
teaching and clinical practice in cardiology has been that, in the absence of symptoms, the
prognosis is usually excellent and, except in a few very specific circumstances, conservative
management and regular review (expectant management) is recommended. This advice is reflected
in current international guidelines but is based largely on historical precedent. There has
never been a randomised controlled trial to address the relative benefits of early AVR versus
expectant management in patients with severe asymptomatic AS. The relative benefits of a
strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe
AS are unclear. There is clinical equipoise but it remains one of the few areas of
cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The
EASY-AS study will provide crucial data on the relative merits of these differing approaches
to management, in terms of important patient orientated outcomes, conventional cardiovascular
end-points and cost effectiveness.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04204915
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gerry McCann, Prof
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Address
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University of Leicester
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carla Richardson
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Address
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Country
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Phone
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0116 229 7936
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04204915
Download to PDF