Future Optimal Research and Care Evaluation - Aortic Stenosis

NCT06168123 | Recruiting

• 1 other identifier: Z23.069
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment. Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.

Conditions

Severe Aortic Valve Stenosis; Moderate Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (3)

• Quality of life as assessed by the EQ-5D-5L

  The EQ-5D-5L is a standardized health-related quality of life instrument that assesses individuals across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It generates a health profile that can be converted into a single index value, commonly ranging from -0.594 to 1, where 1 represents full health, 0 indicates a state equivalent to death, and negative values reflect health states perceived as worse than death.

  Until completion of the study (August 1, 2027)

• Quality of life as assessed by the KCCQ

  The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific instrument assessing heart failure patients across domains such as Total Symptoms, Physical Limitation, and Quality of Life, with scores ranging from 0 to 100. Higher scores indicate better health-related quality of life, while lower scores suggest increased symptomatology and functional limitations in heart failure patients.

  Until completion of the study (August 1, 2027)

• Quality of life as assessed by the SF-12

  The Short Form 12 (SF-12) is a widely used health survey that measures health-related quality of life across physical and mental domains. It generates two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both ranging from 0 to 100, where higher scores indicate better health status, and these summaries provide a concise assessment of an individual's overall physical and mental well-being.

  Until completion of the study (August 1, 2027)

Secondary Outcomes (13)

• Mortality according the VARC-3 criteria

  Until completion of the study (August 1, 2027)

• Neurological events according the VARC-3 criteria

  Until completion of the study (August 1, 2027)

• Hospitalisation according the VARC-3 criteria

  Until completion of the study (August 1, 2027)

• Bleeding and transfusions according the VARC-3 criteria

  Until completion of the study (August 1, 2027)

• Vascular and access-related complications according the VARC-3 criteria

  Until completion of the study (August 1, 2027)

Interventions

Quality of life questionnaires will be assessed in addition to standard care BEHAVIORAL

Quality of life questionnaires will be assessed in addition to standard care

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe or moderate aortic stenosis

You may qualify if:

• Older than 18 years of age
• Severe or moderate aortic stenosis

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Christiaan Overduin

CONTACT

+31 (0)88 320 0931; c.overduin@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: December 13, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2023-12

Locations

NL (1)