Investigating heart changes after aortic valve replacement in severe aortic valve stenosis patients
Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
This study is trying to see how aortic valve replacement surgery affects heart changes in people with severe aortic valve stenosis by looking at heart scans before and after the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen O) |
| Trial ID | NCT05404100 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of aortic valve replacement (AVR) on myocardial fibrosis in patients with severe aortic valve stenosis (AS). Approximately 60 patients scheduled for AVR at Rigshospitalet in Denmark will undergo cardiac magnetic resonance (CMR) imaging before and one year after the procedure. The study will analyze changes in myocardial T1 values to understand the relationship between these changes and various disease or procedural characteristics. The goal is to improve patient selection and treatment timing for better outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe aortic valve stenosis.
Not a fit: Patients with reduced left ventricular ejection fraction or significant left-sided valvular insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of myocardial damage in AS patients and improve treatment strategies.
How similar studies have performed: While the approach of using CMR and T1 mapping is established, the specific application in this context is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Severe aortic valve stenosis (Vmax \> 4 m/s and/or mean gradient \>40 mmHg) Exclusion Criteria: * Reduced left ventricular ejection fraction (\<50%) * More than mild left-sided valvular insufficiency * Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG) * Persistent atrial fibrillation * Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants) * Pacemaker/ICD
Where this trial is running
Copenhagen O
- Rigshospitalet — Copenhagen O, Denmark (Recruiting)
Study contacts
- Study coordinator: Katrine A Myhr, MD
- Email: katrinemyhr@outlook.dk
- Phone: +4571120280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.