Aortic Stenosis - Prognosis, Risk and Outcomes (MASTER)

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis Disease

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Oskar Angerås, MD, PhD; Phone Number: +46 313421000; Email: oskar.angeras@vgregion.se
• Study Contact Backup: Name: Björn Redfors, MD, PhD, Professor; Phone Number: 031342100; Email: bjoern.redfors@wlab.gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Departement of Cardiology,
    • Contact: Oskar Angerås, MD, PhD; Phone Number: +46313421000; Email: oskar.angeras@vgregion.se
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Departement of Cardiology
    • Principal Investigator: Oskar Anerås, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

We will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital

Description

Inclusion Criteria:

• Patient with clinical indication for aortic valve replacement and scheduled for TAVI
• Patient willing and able to provide signed informed consent

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TAVI patients; 300 patients undergoing TAVI at Sahlgrenska University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac damage	To study change in stage of cardiac damage (stage 0-4) by echocardiography.	Baseline and 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in echocardiography parameters	To study E/é ratio in echocardiography derived parameters indicating cardiac damage (delta%)	Baseline and at 14, 30 and 180 days
Change in echocardiography parameters	To study Left ventricular mass change on echocardiography (delta gram)	Baseline and at 14, 30 and 180 days
Left Atrial -strain	To study change in LA-strain derived by echocardiography (delta %)	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)	Baseline and at 14, 30 and 180 days
Cardiac Magnetic Resonance (CMR)	Change in CMR derived parameters Left ventricular mass (delta gram)	Baseline and at 14 and 180 days

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: TAVI; Aortic stenosis; Cardiac remodelling
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EPM Dnr 2024-06746-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No