The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
Launched by RIGSHOSPITALET, DENMARK · Jun 5, 2024
Trial Information
Current as of May 13, 2025
Active, not recruiting
Keywords
ClinConnect Summary
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4) is a study designed to learn more about a condition called aortic valve stenosis, which affects how well the heart can pump blood. Specifically, the trial is looking at patients who have received a type of heart valve replacement called a transcatheter bioprosthetic aortic valve. Researchers want to see how different blood-thinning treatments may affect the thickening of the valve leaflets and whether this thickening is linked to problems like blood clots.
To participate in this trial, patients need to be between 65 and 74 years old, live in Denmark, and have successfully undergone the valve replacement procedure. They should also be able to provide written consent to join the study. However, some patients may not be eligible, including those with certain heart conditions, severe kidney problems, or significant bleeding history. If you join the trial, you can expect to undergo regular check-ups, including scans, to monitor your heart valve and overall health. This study is currently recruiting participants and aims to improve our understanding of heart valve treatments.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients who underwent successful TAVI according to Valve Academic Research Consortium (VARC)-2 criteria
- • Residing in Denmark
- • Provided written informed consent
- Exclusion Criteria:
- • Atrial fibrillation or any other indication for lifelong oral anticoagulant therapy
- • Patient deemed not suitable for DOAC treatment because of previous life-threatening or major bleeding, e.g. intracranial haemorrhage or major gastrointestinal bleeding
- • Patients with severe renal insufficiency (eGFR \<30 mL/min/1.73 m2)
- • Patient with absolute indication for anti-thrombotic therapy, e.g. recent PCI
- • Iodine contrast allergy or other condition that prohibits CT imaging
- • Age \<18 years
- • Women of childbearing potential, pregnant or nursing
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, , Denmark
Aarhus, , Denmark
Patients applied
Trial Officials
Ole De Backer, PhD
Principal Investigator
Rigshospital, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported