Actively Recruiting

Age: 18Years - 110Years
All Genders
ID06168123

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

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years of age
  • Diagnosis of severe or moderate aortic stenosis
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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