Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Launched by RIGSHOSPITALET, DENMARK · May 30, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how aortic valve replacement (AVR) affects heart tissue changes in patients with severe aortic valve stenosis, a condition where the heart's aortic valve becomes narrow and makes it harder for blood to flow. The researchers want to see if the amount of heart muscle damage, known as myocardial fibrosis, improves after surgery and how different factors may influence this change. They will use a special imaging technique called T1 mapping to measure heart muscle health before and one year after the surgery.
To participate in the trial, you need to be at least 18 years old and diagnosed with severe aortic valve stenosis. However, if you have a significantly weakened heart function or certain other heart conditions, you may not be eligible. If you join, you'll undergo heart imaging and clinical evaluations before your surgery and again after a year. This research aims to help doctors determine the best timing for aortic valve replacement in patients, ensuring that more people can receive timely and effective treatment.
Gender
ALL
Eligibility 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
About Rigshospitalet, Denmark
Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Copenhagen O, , Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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