Aortic Stenosis - Prognosis, Risk and Outcomes

NCT06863883 | Not Yet Recruiting

• 1 other identifier: EPM Dnr 2024-06746-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Aortic Stenosis Disease

Keywords

TAVI; Cardiac remodelling; Aortic stenosis

Outcome Measures

Primary Outcomes (1)

• Cardiac damage

  To study change in stage of cardiac damage (stage 0-4) by echocardiography.

  Baseline and 180 days

Secondary Outcomes (5)

• Change in echocardiography parameters

  Baseline and at 14, 30 and 180 days

• Change in echocardiography parameters

  Baseline and at 14, 30 and 180 days

• Left Atrial -strain

  Baseline and at 14, 30 and 180 days

• Change in echocardiography parameters

  Baseline and at 14, 30 and 180 days

• Cardiac Magnetic Resonance (CMR)

  Baseline and at 14 and 180 days

Study Arms (1)

TAVI patients

300 patients undergoing TAVI at Sahlgrenska University Hospital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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
• Estimated glomerular filtration rate \<30 ml/kg/min (CT without contrast can be performed)

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Departement of Cardiology

Gothenburg, 413 45, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples for metabolomics , proteomics and circulating miRNA

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Oskar Angerås, MD, PhD

CONTACT

+46 313421000; oskar.angeras@vgregion.se

Björn Redfors, MD, PhD, Professor

CONTACT

031342100; bjoern.redfors@wlab.gu.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)