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The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study (EASY-AS)

Primary Purpose

Aortic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Aortic valve replacement
Sponsored by
University of Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Stenosis focused on measuring Asymptomatic aortic stenosis, Aortic valve replacement, Randomised controlled trial, Expectant management, Hospitalisation for heart failure, Cardiovascular death

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 written English or availability of a translator to explain the study documentation

    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

Sites / Locations

  • Canberra HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • Westmead HospitalRecruiting
  • Wollongong HospitalRecruiting
  • Prince Charles HospitalRecruiting
  • Townsville HospitalRecruiting
  • The Gold Coast HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Flinders Medical CentreRecruiting
  • Monash HealthRecruiting
  • University Hospital GeelongRecruiting
  • Fiona Stanley HospitalRecruiting
  • Royal Perth HospitalRecruiting
  • Lyell McEwin HospitalRecruiting
  • Northern HospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • Nepean HospitalRecruiting
  • John Hunter HospitalRecruiting
  • Royal Darwin HospitalRecruiting
  • Auckland City HospitalRecruiting
  • Christchurch HospitalRecruiting
  • Dunedin HospitalRecruiting
  • Institute of Cardiovascular DiseasesRecruiting
  • University Hospital of North DurhamRecruiting
  • Glan Clwyd HospitalRecruiting
  • Dorset County HospitalRecruiting
  • Basingstoke and North Hampshire HospitalRecruiting
  • University Hospitals Leicester, GlenfieldRecruiting
  • Royal Liverpool HospitalRecruiting
  • Norfolk and Norwich University HospitalRecruiting
  • Scunthorpe General HospitalRecruiting
  • Kettering General HospitalRecruiting
  • Wansbeck General HospitalRecruiting
  • Raigmore HospitalRecruiting
  • Musgrove Park HospitalRecruiting
  • Morriston HospitalRecruiting
  • Russells Hall HospitalRecruiting
  • George Eliot HospitalRecruiting
  • Walsall Manor HospitalRecruiting
  • Sandwell General HospitalRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • Aintree University HospitalRecruiting
  • Basildon University HospitalRecruiting
  • Queen Elizabeth HospitalRecruiting
  • Blackpool Victoria HospitalRecruiting
  • Royal Sussex County HospitalRecruiting
  • North Cumbria Integrated CareRecruiting
  • County Durham and Darlington NHS Foundation TrustRecruiting
  • Doncaster Royal InfirmaryRecruiting
  • The Royal Infirmary of EdinburghRecruiting
  • Royal Devon & Exeter HospitalRecruiting
  • Huddersfield Royal InfirmaryRecruiting
  • Airedale General HospitalRecruiting
  • Leeds General InfirmaryRecruiting
  • Lincoln County HospitalRecruiting
  • Liverpool Heart and Chest HospitalRecruiting
  • Royal Liverpool Hospital
  • St Bartholomew's HospitalRecruiting
  • St Thomas' HospitalRecruiting
  • University Hospital LewishamRecruiting
  • Imperial College Healthcare NHS TrustRecruiting
  • Maidstone & Tunbridge Wells HospitalRecruiting
  • Wythenshawe HospitalRecruiting
  • North Manchester General HospitalRecruiting
  • The James Cook University HospitalRecruiting
  • Derriford HospitalRecruiting
  • Poole HospitalRecruiting
  • Queen Alexandra HospitalRecruiting
  • Southampton General HospitalRecruiting
  • North Tees and Hartlepool NHS Foundation TrustRecruiting
  • Torbay HospitalRecruiting
  • South Warwickshire University NHS Foundation TrustRecruiting
  • Yeovil District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group A: Aortic valve replacement

Group B: Expectant management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Combined measure of cardiovascular death and hospitalisation for heart failure
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.

Secondary Outcome Measures

WHO Disability Assessment Schedule (WHODAS 2.0)
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).
NHS record linkage services
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.
Death (cardiovascular, including sudden cardiac death, and non-cardiovascular), hospitalisation for heart failure, myocardial infarction, stroke
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.
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
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.
EuroQol five-level (EQ-5D-5L) questionnaire
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.
Health Economics Questionnaire
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.
Edmonton Frail Scale (EFS) (Bedside and Acute Care Version)
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).

Full Information

First Posted
December 17, 2019
Last Updated
September 18, 2023
Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester, The University of Western Australia, University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT04204915
Brief Title
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Acronym
EASY-AS
Official Title
A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
April 1, 2031 (Anticipated)
Study Completion Date
April 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leicester
Collaborators
University Hospitals, Leicester, The University of Western Australia, University of Auckland, New Zealand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a major pragmatic multi-centre prospective parallel group open RCT. It will be conducted in the UK, Australia and New Zealand, funding is being sought in several countries to expand recruitment internationally. The study is in 2 phases: the vanguard and main phase. Therefore the study will run an internal pilot to prove recruitment of the relevant number of participants during the initial 2 years. The over-arching aim is to determine whether early AVR results in better clinical outcomes and cost-effectiveness than a strategy of expectant management in asymptomatic patients with severe AS. The primary hypothesis is that early AVR or TAVI in asymptomatic patients with severe AS will result in a reduction in the composite primary outcome of cardiovascular (CV) death and hospitalisation for heart failure (HHF) when compared to the conventional approach of expectant management. Potential participants will be identified by a member of the clinical care team following diagnosis with severe AS. Participants will be screened for eligibility using pre-specified inclusion/exclusion criteria. Eligible participants will be provided with a written version of the participant information sheet detailing the exact nature of the study, what it will involve for the participant and any risks involved with taking part. Participants will be given at least 24 hours to consider the information and decide whether or not to take part. The study will randomise up to 2844 patients with severe asymptomatic AS to either allocated expectant management OR aortic valve replacement. Participants randomised to AVR will be placed on a waiting list with the aim that surgery will be performed within 3 months, dependent on local hospitals' waiting lists. Participants randomised to AVR will undergo routine tests/procedures which may include coronary angiography. If the outcome of the coronary angiography reveals coronary heart disease, the decision to perform CABG or PCI will be made by the responsible cardiac surgeon and cardiologist, in consultation with the patient. All analyses will be undertaken using the principles of intention-to-treat with participants analysed in the group they were randomised regardless of treatment received. EASY-AS is collaborating with the EVoLVeD study (Early Valve Replacement guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis, Clinical Trials.gov NCT03094143). In centres where both EASY-AS and EVoLVeD are running, participants in EASY-AS will be offered the opportunity to take part in EVoLVeD. Funding has been granted by the British Heart Foundation (UK), Medical Research Future Fund (Aus) and Heart Foundation (NZ). The UK sponsor is the University of Leicester. Additional support and resources for the study will be provided by the participating Trusts and their corresponding Clinical Research Networks in the UK. The central co-ordination centre is the University of Leicester Clinical Trials Unit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
Asymptomatic aortic stenosis, Aortic valve replacement, Randomised controlled trial, Expectant management, Hospitalisation for heart failure, Cardiovascular death

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2844 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Aortic valve replacement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B: Expectant management
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Aortic valve replacement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined measure of cardiovascular death and hospitalisation for heart failure
Description
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.
Time Frame
Minimum 3 years
Secondary Outcome Measure Information:
Title
WHO Disability Assessment Schedule (WHODAS 2.0)
Description
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).
Time Frame
6, 12, 24 and 36 months
Title
NHS record linkage services
Description
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.
Time Frame
Up to 5 years
Title
Death (cardiovascular, including sudden cardiac death, and non-cardiovascular), hospitalisation for heart failure, myocardial infarction, stroke
Description
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.
Time Frame
Up to 5 years
Title
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
Description
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.
Time Frame
Up to 5 years
Title
EuroQol five-level (EQ-5D-5L) questionnaire
Description
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.
Time Frame
6, 12, 24 and 36 months
Title
Health Economics Questionnaire
Description
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.
Time Frame
6, 12, 24 and 36 months
Title
Edmonton Frail Scale (EFS) (Bedside and Acute Care Version)
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years Patient has severe asymptomatic AS, in line with current international guidelines, defined as either: Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR 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 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 The responsible clinician feels that either ongoing surveillance or early AVR are appropriate. Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk Willing to provide informed consent and be randomised to early AVR or expectant management 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 Exclusion Criteria: Symptoms related to AS Additional severe valvular heart disease Other cardiac surgery planned pre-randomisation (eg CABG) Left ventricular systolic dysfunction (LVEF <50%) Pregnancy Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to <2 years Patient has previously undergone AVR or TAVI with restenosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Richardson
Phone
0116 229 7936
Ext
7936
Email
easyas@leicester.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Walters
Email
easyas@leicester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerry McCann, Prof
Organizational Affiliation
University of Leicester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Hillis, Prof
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ralph Stewart, Prof
Organizational Affiliation
University of Aukland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canberra Hospital
City
Garran
State/Province
Canberra
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Walter Abhayaratna
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Dominic Leung
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Ravinay Bhindi
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Dylan Wynne
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Edward Danson
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dale Murdoch
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Lim Eng
Facility Name
The Gold Coast Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kuljit Singh
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Jerrett Lau
Facility Name
Flinders Medical Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Joseph Selvanayagam
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Julian Smith
Facility Name
University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A/Professor John Amerena
Facility Name
Fiona Stanley Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Gerald Yong
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
WA6000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Graham Hillis
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
ZIP/Postal Code
SA 5112
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Luan Huynh
Facility Name
Northern Hospital
City
Epping
ZIP/Postal Code
VIC 3076
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Chiew Wong
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
TAS 7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Ashutosh Hardikar
Facility Name
Nepean Hospital
City
Kingswood
ZIP/Postal Code
NSW 2747
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Kaz Negishi
Facility Name
John Hunter Hospital
City
New Lambton Heights
ZIP/Postal Code
NSW 2305
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A/Professor Aaron Sverdlov
Facility Name
Royal Darwin Hospital
City
Tiwi
ZIP/Postal Code
TIWI NT 0810
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Hussam Tayeb
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Ralph Stewart
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Philip Adamson
Facility Name
Dunedin Hospital
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Sean Coffey
Facility Name
Institute of Cardiovascular Diseases
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazar Velicki
Facility Name
University Hospital of North Durham
City
Durham
State/Province
County Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darragh Darragh Twomey
Facility Name
Glan Clwyd Hospital
City
Bodelwyddan
State/Province
Denbighshire
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satheesh Nair
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fraser Witherow
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Jason Glover
Facility Name
University Hospitals Leicester, Glenfield
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Anvesha Singh
Facility Name
Royal Liverpool Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8YE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prathap Kanagala
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Vassilios Vassiliou
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
North Lincolnshire
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rashed Hossain
Facility Name
Kettering General Hospital
City
Kettering
State/Province
Northamptonshire
ZIP/Postal Code
NN16 8UZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kai Hogrefe
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
Northumberland
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr David Ripley
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Leslie
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Rees
Facility Name
Morriston Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Chase
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Barr
Facility Name
George Eliot Hospital
City
Nuneaton
State/Province
West Midlands
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Krishnamoorthy
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
West Midlands
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rumi Jaumdally
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
West Midlands
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Maher
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Ciprian Dospinescu
First Name & Middle Initial & Last Name & Degree
Mr Hussein El-Shafei
Facility Name
Aintree University Hospital
City
Aintree
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Prathap Kanagala
Facility Name
Basildon University Hospital
City
Basildon
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Jason Dungu
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Rick Steeds
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Nidal Bittar
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr David Hildick-Smith
Facility Name
North Cumbria Integrated Care
City
Carlisle
ZIP/Postal Code
CA2 7AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Rhidian Shelton
Facility Name
County Durham and Darlington NHS Foundation Trust
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Darragh Twomey
Facility Name
Doncaster Royal Infirmary
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Gillian Payne
Facility Name
The Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Marc Dweck
First Name & Middle Initial & Last Name & Degree
Professor David Newby
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Andrew Ludman
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Hossam El Mahy
Facility Name
Airedale General Hospital
City
Keighley
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Haqeel Jamil
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor John Greenwood
Facility Name
Lincoln County Hospital
City
Lincoln
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kelvin Lee
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Timothy Fairbairn
Facility Name
Royal Liverpool Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Prathap Kanagala
First Name & Middle Initial & Last Name & Degree
Dr Michael Fisher
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Thomas Treibel
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Ronak Rajani
Facility Name
University Hospital Lewisham
City
London
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Amar Singh
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Jamil Mayet
Facility Name
Maidstone & Tunbridge Wells Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Timothy Williams
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Laura Dobson
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Laura Dobson
First Name & Middle Initial & Last Name & Degree
Dr Ahmed Adlan
Facility Name
The James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Jeet Thambyrajah
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Sivasankar Sangaraju
First Name & Middle Initial & Last Name & Degree
Mr Sanjay Asopa
Facility Name
Poole Hospital
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Chris Steadman
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Peter Haworth
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Nick Curzen
First Name & Middle Initial & Last Name & Degree
Mr Sunil Ohri
Facility Name
North Tees and Hartlepool NHS Foundation Trust
City
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Paul Davison
Facility Name
Torbay Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Usman Sheikh
Facility Name
South Warwickshire University NHS Foundation Trust
City
Warwick
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr John Fryearson
Facility Name
Yeovil District Hospital
City
Yeovil
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Andrew Broadley

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

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