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Search / Trial NCT05404100

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

Aortic Valve Stenosis Aortic Valve Replacement Myocardial Fibrosis Cardiac Magnetic Resonance T1 Mapping

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.

Locations

Copenhagen O, , Denmark

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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