Aortic Stenosis DiseaseMASTERNCT06863883
Aortic Stenosis - Prognosis, Risk and Outcomes
An observational study of Aortic Stenosis Disease, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden. Eligible patients should have a clinical indication for aortic valve replacement with TAVI and have preprocedural clinical investigations with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis Disease
- How many people
- 300 participants
- Where
- 2 sitesSweden
- Study dates
- 4 Mar 2025to Jun 2031
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital
Who may be able to join
- Patient with clinical indication for aortic valve replacement and scheduled for TAVI
- Patient willing and able to provide signed informed consent
Who cannot join
- Inability to provide informed consent Additional exclusion criteria for MRI
- Estimated glomerular filtration rate <30 ml/kg/min (MRI without contrast can be performed )
- Claustrophobia or inability to tolerate confined spaces.
- Non-compatible metal device present in body
- Any other contra-indications for MRI as per local guidelines Additional exclusion criteria for the CT substudy
- Estimated glomerular filtration rate <30 ml/kg/min (CT without contrast can be performed)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Departement of Cardiology,
Gothenburg, 413 45
Oskar Angerås, MD, PhD, +46313421000, oskar.angeras@vgregion.se
- Recruiting
Departement of Cardiology
Gothenburg, 413 45
Oskar Anerås, MD, PhD
About this study
Official title: Measuring Outcomes in Aortic STenosis Patients Undergoing AVR - Evaluation of Prognosis Regarding Short- and Long-term Results (MASTER)
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden. Eligible patients should have a clinical indication for aortic valve replacement with TAVI and have preprocedural clinical investigations with echocardiography (UCG) and CCT and provide written informed consent. UCG, electrocardiogram (ECG) and blood samples will be taken in addition to clinical status, NYHA-class and collection of outcome events the day before the procedure, 1±2 hours, 24 ±6hours and daily after the procedure until discharged from Sahlgrenska. Further follow-up will be scheduled day 14, 30, 180, 365 and yearly. Cardiac MRI will be performed before, at 14 days and at 180 days after TAVI. Brain MRI will be performed before and 24± hours after TAVI. Cardiac CT will be performed at 180 days after TAVI.
Read the detailed description
- Study procedures UCG, cardiac CT and ECG before the TAVI procedure are done as standard of care. Study-related imaging procedures are non-invasive methods that carry no risk of serious adverse events for the study subject.
- Ultrasound cardiogram (UCG) UCG is a non-invasive imaging procedure that uses ultrasound to image the heart in real- time. UCG carries no risk of causing serious adverse events for the study participants.
- Quality of life Quality of life will be assessed using EQ-5D-5L at baseline and at 14 days, 30 days, 180 days and yearly after the procedure.
- ECG ECG has been the cornerstone of cardiovascular medicine for decades and is part of routine clinical practice for all patients undergoing TAVI at cardiology departments across the world. It is a non-invasive test that carries no risk of serious adverse events.
- MRI Cardiac Magnetic Resonance imaging (CMR) will be used to assess the degree of cardiac remodeling and hemodynamic and blood flow parameters, e.g. turbulence, as a sub-study within in the larger study. Brain Magnetic Resonance imaging (brain MRI) will be used to assess micro-embolism and ischemic stroke related to the TAVI procedure.
CMR and Brain MRI poses no increased risk of causing serious adverse events for patients participating in the study. However, patients with clear contraindication will not be included to the study. (e.g. patients with MRI non-compatible metal device present in body, claustrophobia or for other reasons set at the local clinic). Patients with kidney failure (estimated glomerular filtration rate <30 ml/kg/min,) will not be given MRI contrast medium.
MRI is planned before the TAVI procedure (baseline), 24 hours (Brain MRI) and at 180 days (CMR) after TAVI.
- Cardiac CT Cardiac CT before TAVI is part of routine clinical care and used for procedural planning. An additional cardiac CT will be performed as a sub-study at 180 days after the TAVI procedure. The procedure will be used to assess the placement of the TAVI-valve in the native aortic annulus, e.g. the depth of the valve, the alignment of the commissures of the prothesis in relation the native commissures and the coronary ostia and be used to simulate the possibilities to perform a redo-TAVI if the need should arise. Patients with kidney failure (estimated glomerular filtration rate <30 ml/kg/min,) will not be given CT contrast medium.
- Storing of blood samples for future analysis Plan to save blood samples (for subjects that have consented to this part) for the purpose of future analysis for metabolomics, proteomics and circulating miRNA. The amount of blood for biobank storage will be 21 ml collected at four time points per study participant, i.e. max 84 ml per patients.
- Conditions
- Aortic Stenosis Disease
- Keywords
- TAVI, Cardiac remodelling, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAVI patients | 300 patients undergoing TAVI at Sahlgrenska University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac damage
To study change in stage of cardiac damage (stage 0-4) by echocardiography.
Measured: Baseline and 180 days
Secondary outcomes (5)
Change in echocardiography parameters
To study E/é ratio in echocardiography derived parameters indicating cardiac damage (delta%)
Measured: Baseline and at 14, 30 and 180 days
Change in echocardiography parameters
To study Left ventricular mass change on echocardiography (delta gram)
Measured: Baseline and at 14, 30 and 180 days
Left Atrial -strain
To study change in LA-strain derived by echocardiography (delta %)
Measured: Baseline and at 14, 30 and 180 days
Change in echocardiography parameters
To study the influence of effectiv orfice area (cm2)of the aortic valve on cardiac damage (stage 0-4)
Measured: Baseline and at 14, 30 and 180 days
Cardiac Magnetic Resonance (CMR)
Change in CMR derived parameters Left ventricular mass (delta gram)
Measured: Baseline and at 14 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start4 Mar 2025
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis DiseaseStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863883
- Sponsor's protocol ID
- EPM Dnr 2024-06746-01
- Acronym
- MASTER
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Outcomes in Aortic STenosis Patients Undergoing AVR - Evaluation of Prognosis Regarding Short- and Long-term Results (MASTER)
- ClinicalTrials.gov ID
- NCT06863883
- Acronym / sponsor ID
- MASTER / EPM Dnr 2024-06746-01
- Conditions
- Aortic Stenosis Disease
- Keywords
- TAVI, Cardiac remodelling, Aortic stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 7 Mar 2025 (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.
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden. Eligible patients should have a clinical indication for aortic valve replacement with TAVI and have preprocedural clinical investigations with echocardiography (UCG) and CCT and provide written informed consent. UCG, electrocardiogram (ECG) and blood samples will be taken in addition to clinical status, NYHA-class and collection of outcome events the day before the procedure, 1±2 hours, 24 ±6hours and daily after the procedure until discharged from Sahlgrenska. Further follow-up will be scheduled day 14, 30, 180, 365 and yearly. Cardiac MRI will be performed before, at 14 days and at 180 days after TAVI. Brain MRI will be performed before and 24± hours after TAVI. Cardiac CT will be performed at 180 days after TAVI.
Detailed description
- Study procedures UCG, cardiac CT and ECG before the TAVI procedure are done as standard of care. Study-related imaging procedures are non-invasive methods that carry no risk of serious adverse events for the study subject.
- Ultrasound cardiogram (UCG) UCG is a non-invasive imaging procedure that uses ultrasound to image the heart in real- time. UCG carries no risk of causing serious adverse events for the study participants.
- Quality of life Quality of life will be assessed using EQ-5D-5L at baseline and at 14 days, 30 days, 180 days and yearly after the procedure.
- ECG ECG has been the cornerstone of cardiovascular medicine for decades and is part of routine clinical practice for all patients undergoing TAVI at cardiology departments across the world. It is a non-invasive test that carries no risk of serious adverse events.
- MRI Cardiac Magnetic Resonance imaging (CMR) will be used to assess the degree of cardiac remodeling and hemodynamic and blood flow parameters, e.g. turbulence, as a sub-study within in the larger study. Brain Magnetic Resonance imaging (brain MRI) will be used to assess micro-embolism and ischemic stroke related to the TAVI procedure.
CMR and Brain MRI poses no increased risk of causing serious adverse events for patients participating in the study. However, patients with clear contraindication will not be included to the study. (e.g. patients with MRI non-compatible metal device present in body, claustrophobia or for other reasons set at the local clinic). Patients with kidney failure (estimated glomerular filtration rate <30 ml/kg/min,) will not be given MRI contrast medium.
MRI is planned before the TAVI procedure (baseline), 24 hours (Brain MRI) and at 180 days (CMR) after TAVI.
- Cardiac CT Cardiac CT before TAVI is part of routine clinical care and used for procedural planning. An additional cardiac CT will be performed as a sub-study at 180 days after the TAVI procedure. The procedure will be used to assess the placement of the TAVI-valve in the native aortic annulus, e.g. the depth of the valve, the alignment of the commissures of the prothesis in relation the native commissures and the coronary ostia and be used to simulate the possibilities to perform a redo-TAVI if the need should arise. Patients with kidney failure (estimated glomerular filtration rate <30 ml/kg/min,) will not be given CT contrast medium.
- Storing of blood samples for future analysis Plan to save blood samples (for subjects that have consented to this part) for the purpose of future analysis for metabolomics, proteomics and circulating miRNA. The amount of blood for biobank storage will be 21 ml collected at four time points per study participant, i.e. max 84 ml per patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI patients | – | –300 patients undergoing TAVI at Sahlgrenska University Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital
Key inclusion criteria (2 listed)
- Patient with clinical indication for aortic valve replacement and scheduled for TAVI
- Patient willing and able to provide signed informed consent
Key exclusion criteria (6 listed)
- Inability to provide informed consent Additional exclusion criteria for MRI
- Estimated glomerular filtration rate <30 ml/kg/min (MRI without contrast can be performed )
- Claustrophobia or inability to tolerate confined spaces.
- Non-compatible metal device present in body
- Any other contra-indications for MRI as per local guidelines Additional exclusion criteria for the CT substudy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac damage
Time frame: Baseline and 180 days
To study change in stage of cardiac damage (stage 0-4) by echocardiography.
5 secondary outcomes
Change in echocardiography parameters
Time frame: Baseline and at 14, 30 and 180 days
Change in echocardiography parameters
Time frame: Baseline and at 14, 30 and 180 days
Left Atrial -strain
Time frame: Baseline and at 14, 30 and 180 days
Change in echocardiography parameters
Time frame: Baseline and at 14, 30 and 180 days
Cardiac Magnetic Resonance (CMR)
Time frame: Baseline and at 14 and 180 days
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 2 Jun 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis Disease, run by Vastra Gotaland Region at 2 sites in Sweden.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Oskar Angerås, MD, PhD (+46 313421000, oskar.angeras@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac damage (time frame: Baseline and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.