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NCT Number: NCT06168123

Future Optimal Research and Care Evaluation - Aortic Stenosis

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.

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Key information

Conditions

Severe Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Moderate Aortic Valve Stenosis Ventricular Outflow Obstruction

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Antonius Hospital

Nieuwegein, Netherlands

Location status: Recruiting

Location contact

Jurrien ten berg, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

No exclusion criteria are applicable to this registry

Treatment and study plan

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

Primary outcomes

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

    Time frame: Until completion of the study (August 1, 2027)

    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.

  2. Quality of life as assessed by the KCCQ

    Time frame: Until completion of the study (August 1, 2027)

    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.

  3. Quality of life as assessed by the SF-12

    Time frame: Until completion of the study (August 1, 2027)

    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.

Secondary outcomes

  1. Mortality according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  2. Neurological events according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  3. Hospitalisation according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  4. Bleeding and transfusions according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  5. Vascular and access-related complications according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  6. Cardiac structural complications according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  7. Other procedural or valve-related complications according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  8. New conduction disturbances and arrhythmias according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  9. Acute kidney injury according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  10. Myocardial infarction according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  11. Bioprosthetic valve dysfunction according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  12. Leaflet thickening and reduced motion according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

  13. Clinically significant valve thrombosis according the VARC-3 criteria

    Time frame: Until completion of the study (August 1, 2027)

    The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Christiaan Overduin

CONTACT

[email protected]

+31 (0)88 320 0931

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Acronym: FORCE-AoS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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