Actively Recruiting
Future Optimal Research and Care Evaluation - Aortic Stenosis
Led by St. Antonius Hospital · Updated on 2024-12-03
800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with moderate to severe aortic valve stenosis to understand the impact of different treatment methods on quality of life and survival. The study evaluates surgical aortic valve replacement, transcatheter aortic valve implantation, and conservative treatment to determine the best lifetime management approach for each patient. This observational study addresses important questions about treatment durability and antithrombotic therapy. Participants will receive standard care while their quality of life is assessed using questionnaires such as the EQ-5D-5L, KCCQ, and SF-12 throughout the study. The study does not involve assigning specific treatments but monitors outcomes related to the treatment choices patients and their doctors decide on in routine care. During the study, participants will complete quality of life questionnaires and researchers will track various health events and complications until the study ends in August 2027. These include mortality, neurological events, hospitalizations, bleeding, cardiac complications, and valve function, all measured according to established VARC-3 criteria. Participants can expect regular evaluations as part of their ongoing care.
CONDITIONS
Brief Title
Future Optimal Research and Care Evaluation - Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years of age
- Diagnosis of severe or moderate aortic stenosis
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to August 1, 2027
Participants are observed over time with quality of life questionnaires and health events recorded alongside standard care.
Ongoing assessments during routine care
Trial Site Locations
Total: 1 location
1
St. Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
Research Team
C
Christiaan Overduin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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