Aortic Valve StenosisEVoLVeDNCT03094143

Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS

A study testing Aortic valve intervention in people with Aortic Valve Stenosis and Hypertrophy, Left Ventricular, run by University of Edinburgh at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis, Hypertrophy, Left Ventricular
What is being tested?: Aortic valve intervention
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteUnited Kingdom
Study dates: 21 Jul 2017to 30 Jun 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area indexed to body surface area <0.6cm2/m2 with aortic jet velocity ≥3.5m/s)
Age over 18 years
No symptoms attributable to aortic stenosis that require aortic valve replacement

Who cannot join

Deemed lower risk for mid-wall fibrosis on screening
Planned cardiac surgery
Previous valve replacement
Severe hypertension (systolic >180 or diastolic >110 mmHg)
Acute pulmonary oedema or cardiogenic shock
Left ventricular ejection fraction <50% on cardiac MRI

Show all 17Show fewer

Significant abnormalities on cardiac MRI that would prevent enrolment
Coexistent severe aortic regurgitation or mitral regurgitation
Coexistent mitral stenosis greater than mild in severity
Coexistent hypertrophic cardiomyopathy or cardiac amyloidosis
Any contraindication to MRI scanning (such as permanent pacemaker)
Advanced renal impairment (glomerular filtration rate <30 mL/min/1.73 m2)
Pregnancy or breast feeding
Patient judged to be unfit to be considered for aortic valve replacement or transcatheter aortic valve implantation
Patient declines to consider undergoing valve replacement surgery or transcatheter aortic valve implantation
Inability to give informed consent
Previous randomisation into this study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

NHS Lothian
Edinburgh

Other trials in United Kingdom

About this study

Official title: Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients With Severe Aortic Stenosis

Aortic stenosis is the most common valvular disease in the Western world. It is caused by progressive narrowing of the aortic valve leading to increased strain on the heart muscle which has to work increasingly hard to pump blood through the narrowed valve. Over time the heart muscle thickens to generate more force, but eventually the heart fails leading to death if the valve is not replaced with an operation. No medical treatments exist to stop or reverse the heart valve narrowing. Current clinical guidelines suggest that an operation should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the heart muscle has become irreversibly damaged and the heart fails to recover following surgery.

Using MRI scans of the heart, the investigators have identified heart scarring which seems to develop as the heart muscle thickens. Several studies now show that people who have developed this scarring are more likely to suffer poor outcomes including death. The investigators have also identified clinical risks that predict the presence of scarring.

The investigators propose a study where patients with severe aortic stenosis but no indications for valve replacement as per current guidelines are assessed for those clinical risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI scan. If scarring is present participants will be randomised to routine clinical care, or referral for valve replacement surgery. Participants with no evidence of scarring will be randomised routine care with study follow or not. The investigators of this study hypothesize that early surgery will lead to fewer complications and reduced risk of death compared to standard care.

Conditions: Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Being tested: Aortic valve intervention
Medical subject headings: Aortic Valve Stenosis, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aortic valve interventionProcedure or surgery
The choice of either surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) will be made by the local clinical team according to local policies. In patients undergoing surgical replacement the choice of surgical technique and type of valve replacement used will be at the discretion of the operating surgeon. Patients found to have significant coronary artery disease requiring concomitant coronary artery bypass surgery will not be excluded. Similarly the choice of TAVI valve and need for percutaneous coronary intervention will be made by the TAVI heart team. The procedure should be performed as soon as possible and ideally within four months of randomisation and allocation to group A.

Study groups in NCT03094143
Study group	Role	What they receive
Group A: Early intervention	Experimental	Patients will be referred immediately for aortic valve intervention. Receives: Procedure: Aortic valve intervention
Group B: Routine care	No intervention	Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the participant's clinical team (cardiologist and cardiac surgeon).
Group C: Routine care	No intervention	Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). Group C will appear identical to Group B
Group D: No further study follow up	No intervention	Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). No further study follow up will take place but personal data will be retained for future data linkage.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of all-cause mortality or unplanned aortic stenosis-related hospitalisation
The first event of all-cause mortality or unplanned aortic stenosis-related hospitalisation
Unplanned aortic stenosis-related hospitalisation is defined as an unplanned admission with syncope, heart failure, chest pain or arrhythmia (ventricular arrhythmia or second or third degree heart block) attributed to aortic stenosis. This endpoint will be adjudicated by two independent investigators blinded to the details of randomisation following review of the case notes and hospital records.
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)

Secondary outcomes (12)

All-cause mortality
Measured: Randomisation through to study completion, an average of 2.75 years
Cardiovascular death
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
AS-related death
AS-related death is a death where aortic stenosis has been listed as a contributory cause by the clinical care team on the patient's official death certificate.
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Sudden cardiac death
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Unplanned aortic-stenosis related hospitalisation
Unplanned aortic stenosis-related hospitalisation is defined as an unplanned admission with syncope, heart failure, chest pain or arrhythmia (ventricular arrhythmia or second or third degree heart block) attributed to aortic stenosis.
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
WHODAS 2.0 (12 item)
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a generic assessment instrument developed by WHO to provide a standardized method for measuring health and disability across cultures.
Measured: At study completion (mean follow up is expected to be an average of 2.75 years)
LV systolic function
The development of LV systolic dysfunction (EF <50% quantitatively or at least mild LV dysfunction qualitatively)
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
NYHA status
Self reported patient symptoms on a scale of I-IV (I = No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, IV = Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.)
Measured: At study completion (mean follow up is expected to be an average of 2.75 years)
Permanent pacemaker insertion, cardiac resynchronisation therapy or automated implantable cardioverter defibrillator
To compare between study arms the number of participants who have had a permanent pacemaker insertion, cardiac resynchronisation therapy or automated implantable cardioverter defibrillator
Measured: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Stroke
Measured: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Endocarditis
To compare between study arms the number of participants who have endocarditis
Measured: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Post-operative complications following aortic valve intervention
Measured: 30 days post aortic valve intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 201730 Jun 2032

First posted29 Mar 2017
Study start21 Jul 2017
Primary completion1 Jul 2024
Study completion30 Jun 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by University of EdinburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: \~1000 patients with asymptomatic severe aortic stenosis will be screened across the sites (this is how we have defined enrollment below). Patients at high risk of left ventricular decompensation based on high-sensitivity troponin or ECG will proceed to CMR. Participants are randomised based on the result of the cardiac MRI. Participants who have mid wall fibrosis (heart scarring) are randomised to receive either early surgical intervention (group A) or routine care (group B). Participants who have no mid wall fibrosis are randomised to routine care with study follow up (group C) or without study follow up (group D).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03094143
Sponsor's protocol ID: 15/JTA
Acronym: EVoLVeD
Status last verified: Sep 2026
First submitted: 10 Mar 2017
Last updated: 27 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: It is planned that an anonymised raw dataset will be shared under a controlled access model. It will be available following primary publication. Requests will be made in accordance with Edinburgh Clinical Trials Unit policy at the time of release.

Publications

Craig NJ, Loganath K, Everett RJ, Bing R, Ramtoola T, Tsampasian V, Molek P, Botezatu S, Aslam S, MacGillivray T, Tuck CE, Rayson P, Calvert PA, Berry C, Chin CWL, Hillis GS, Fairbairn T, Greenwood JP, Steeds R, Leslie SJ, Lang CC, Bucciarelli-Ducci C, Joshi NV, Kunadian V, Prendergast B, Mills NL, Vassiliou VS, Dungu JN, Hothi SS, Boon N, Prasad SK, Keenan NG, Dawson D, Motwani M, Miller CA, Rajani R, Ripley DP, Treibel TA, McCann GP, Singh A, Newby DE, Dweck MR; EVOLVED investigators. Myocardial Fibrosis and Early Intervention in Asymptomatic Patients With Severe Aortic Stenosis: Insights From the EVOLVED Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):599-605. doi: 10.1001/jamacardio.2026.0654.
PubMed 41984459
Loganath K, Craig NJ, Everett RJ, Bing R, Tsampasian V, Molek P, Botezatu S, Aslam S, Lewis S, Graham C, White AC, MacGillivray T, Tuck CE, Rayson P, Cranley D, Irvine S, Armstrong R, Milne L, Chin CWL, Hillis GS, Fairbairn T, Greenwood JP, Steeds R, Leslie SJ, Lang CC, Bucciarelli-Ducci C, Joshi NV, Kunadian V, Vassiliou VS, Dungu JN, Hothi SS, Boon N, Prasad SK, Keenan NG, Dawson D, Treibel TA, Motwani M, Miller CA, Mills NL, Rajani R, Ripley DP, McCann GP, Prendergast B, Singh A, Newby DE, Dweck MR; EVOLVED investigators. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):213-221. doi: 10.1001/jama.2024.22730.
PubMed 39466640
Patel KP, Scully PR, Saberwal B, Sinha A, Yap-Sanderson JJL, Cheasty E, Mullen M, Menezes LJ, Moon JC, Pugliese F, Klotz E, Treibel TA. Regional Distribution of Extracellular Volume Quantified by Cardiac CT in Aortic Stenosis: Insights Into Disease Mechanisms and Impact on Outcomes. Circ Cardiovasc Imaging. 2024 May;17(5):e015996. doi: 10.1161/CIRCIMAGING.123.015996. Epub 2024 May 21.
PubMed 38771906
Di Pietro E, Frittitta V, Motta S, Strazzieri O, Valvo R, Reddavid C, Costa G, Tamburino C. Treatment in patients with severe asymptomatic aortic stenosis: is it best not to wait? Eur Heart J Suppl. 2022 Nov 12;24(Suppl I):I170-I174. doi: 10.1093/eurheartjsupp/suac089. eCollection 2022 Nov.
PubMed 36380774
Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, Kirkeeide RL, Gould KL, Johnson NP. Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions. J Interv Cardiol. 2020 Jul 22;2020:4603169. doi: 10.1155/2020/4603169. eCollection 2020.
PubMed 32774184
Bing R, Everett RJ, Tuck C, Semple S, Lewis S, Harkess R, Mills NL, Treibel TA, Prasad S, Greenwood JP, McCann GP, Newby DE, Dweck MR. Rationale and design of the randomized, controlled Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial. Am Heart J. 2019 Jun;212:91-100. doi: 10.1016/j.ahj.2019.02.018. Epub 2019 Mar 15.
PubMed 30978556

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients With Severe Aortic Stenosis
ClinicalTrials.gov ID: NCT03094143
Acronym / sponsor ID: EVoLVeD / 15/JTA
Conditions: Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,000 participants (estimated)
Lead sponsor: University of EdinburghUniversity, hospital or other
Collaborators: Sir Jules Thorn Charitable Trust
Study start: 21 Jul 2017 (actual)
Primary completion: 1 Jul 2024 (actual)
Study completion: 30 Jun 2032 (estimated)
First posted: 29 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: ~1000 patients with asymptomatic severe aortic stenosis will be screened across the sites (this is how we have defined enrollment below). Patients at high risk of left ventricular decompensation based on high-sensitivity troponin or ECG will proceed to CMR. Participants are randomised based on the result of the cardiac MRI. Participants who have mid wall fibrosis (heart scarring) are randomised to receive either early surgical intervention (group A) or routine care (group B). Participants who have no mid wall fibrosis are randomised to routine care with study follow up (group C) or without study follow up (group D).

Arm	Type	Receives
Group A: Early intervention	Experimental	Procedure: Aortic valve interventionPatients will be referred immediately for aortic valve intervention.
Group B: Routine care	No intervention	–Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the participant's clinical team (cardiologist and cardiac surgeon).
Group C: Routine care	No intervention	–Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). Group C will appear identical to Group B
Group D: No further study follow up	No intervention	–Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). No further study follow up will take place but personal data will be retained for future data linkage.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area indexed to body surface area <0.6cm2/m2 with aortic jet velocity ≥3.5m/s)
Age over 18 years
No symptoms attributable to aortic stenosis that require aortic valve replacement

Key exclusion criteria (17 listed)

Deemed lower risk for mid-wall fibrosis on screening
Planned cardiac surgery
Previous valve replacement
Severe hypertension (systolic >180 or diastolic >110 mmHg)
Acute pulmonary oedema or cardiogenic shock

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aortic valve interventionThe choice of either surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) will be made by the local clinical team according to local policies. In patients undergoing surgical replacement the choice of surgical technique and type of valve replacement used will be at the discretion of the operating surgeon. Patients found to have significant coronary artery disease requiring concomitant coronary artery bypass surgery will not be excluded. Similarly the choice of TAVI valve and need for percutaneous coronary intervention will be made by the TAVI heart team. The procedure should be performed as soon as possible and ideally within four months of randomisation and allocation to group A.	Procedure or surgery	Group A: Early intervention

Primary outcome

Composite of all-cause mortality or unplanned aortic stenosis-related hospitalisation
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
The first event of all-cause mortality or unplanned aortic stenosis-related hospitalisation Unplanned aortic stenosis-related hospitalisation is defined as an unplanned admission with syncope, heart failure, chest pain or arrhythmia (ventricular arrhythmia or second or third degree heart block) attributed to aortic stenosis. This endpoint will be adjudicated by two independent investigators blinded to the details of randomisation following review of the case notes and hospital records.

12 secondary outcomes

All-cause mortality
Time frame: Randomisation through to study completion, an average of 2.75 years
Cardiovascular death
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
AS-related death
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Sudden cardiac death
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Unplanned aortic-stenosis related hospitalisation
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
WHODAS 2.0 (12 item)
Time frame: At study completion (mean follow up is expected to be an average of 2.75 years)
LV systolic function
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
NYHA status
Time frame: At study completion (mean follow up is expected to be an average of 2.75 years)
Permanent pacemaker insertion, cardiac resynchronisation therapy or automated implantable cardioverter defibrillator
Time frame: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Stroke
Time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)
Endocarditis
Time frame: Randomisation to through to study completion (mean follow up is expected to be an average of 2.75 years)
Post-operative complications following aortic valve intervention
Time frame: 30 days post aortic valve intervention

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Derived from this study: PubMed 41984459Craig NJ, Loganath K, Everett RJ, Bing R, Ramtoola T, Tsampasian V, Molek P, Botezatu S, Aslam S, MacGillivray T, Tuck CE, Rayson P, Calvert PA, Berry C, Chin CWL, Hillis GS, Fairbairn T, Greenwood JP, Steeds R, Leslie SJ, Lang CC, Bucciarelli-Ducci C, Joshi NV, Kunadian V, Prendergast B, Mills NL, Vassiliou VS, Dungu JN, Hothi SS, Boon N, Prasad SK, Keenan NG, Dawson D, Motwani M, Miller CA, Rajani R, Ripley DP, Treibel TA, McCann GP, Singh A, Newby DE, Dweck MR; EVOLVED investigators. Myocardial Fibrosis and Early Intervention in Asymptomatic Patients With Severe Aortic Stenosis: Insights From the EVOLVED Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):599-605. doi: 10.1001/jamacardio.2026.0654.
Derived from this study: PubMed 39466640Loganath K, Craig NJ, Everett RJ, Bing R, Tsampasian V, Molek P, Botezatu S, Aslam S, Lewis S, Graham C, White AC, MacGillivray T, Tuck CE, Rayson P, Cranley D, Irvine S, Armstrong R, Milne L, Chin CWL, Hillis GS, Fairbairn T, Greenwood JP, Steeds R, Leslie SJ, Lang CC, Bucciarelli-Ducci C, Joshi NV, Kunadian V, Vassiliou VS, Dungu JN, Hothi SS, Boon N, Prasad SK, Keenan NG, Dawson D, Treibel TA, Motwani M, Miller CA, Mills NL, Rajani R, Ripley DP, McCann GP, Prendergast B, Singh A, Newby DE, Dweck MR; EVOLVED investigators. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):213-221. doi: 10.1001/jama.2024.22730.
Derived from this study: PubMed 38771906Patel KP, Scully PR, Saberwal B, Sinha A, Yap-Sanderson JJL, Cheasty E, Mullen M, Menezes LJ, Moon JC, Pugliese F, Klotz E, Treibel TA. Regional Distribution of Extracellular Volume Quantified by Cardiac CT in Aortic Stenosis: Insights Into Disease Mechanisms and Impact on Outcomes. Circ Cardiovasc Imaging. 2024 May;17(5):e015996. doi: 10.1161/CIRCIMAGING.123.015996. Epub 2024 May 21.
Derived from this study: PubMed 36380774Di Pietro E, Frittitta V, Motta S, Strazzieri O, Valvo R, Reddavid C, Costa G, Tamburino C. Treatment in patients with severe asymptomatic aortic stenosis: is it best not to wait? Eur Heart J Suppl. 2022 Nov 12;24(Suppl I):I170-I174. doi: 10.1093/eurheartjsupp/suac089. eCollection 2022 Nov.
Derived from this study: PubMed 32774184Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, Kirkeeide RL, Gould KL, Johnson NP. Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions. J Interv Cardiol. 2020 Jul 22;2020:4603169. doi: 10.1155/2020/4603169. eCollection 2020.
Derived from this study: PubMed 30978556Bing R, Everett RJ, Tuck C, Semple S, Lewis S, Harkess R, Mills NL, Treibel TA, Prasad S, Greenwood JP, McCann GP, Newby DE, Dweck MR. Rationale and design of the randomized, controlled Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients with Severe Aortic Stenosis (EVOLVED) trial. Am Heart J. 2019 Jun;212:91-100. doi: 10.1016/j.ahj.2019.02.018. Epub 2019 Mar 15.
Individual participant dataSharing planned: Yes. It is planned that an anonymised raw dataset will be shared under a controlled access model. It will be available following primary publication. Requests will be made in accordance with Edinburgh Clinical Trials Unit policy at the time of release.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Dweck principal investigator

University of Edinburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aortic valve intervention in people with Aortic Valve Stenosis and Hypertrophy, Left Ventricular, run by University of Edinburgh at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause mortality or unplanned aortic stenosis-related hospitalisation (time frame: Randomisation through to study completion (mean follow up is expected to be an average of 2.75 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094143, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.