Future Optimal Research and Care Evaluation - Aortic Stenosis (FORCE-AoS)

December 4, 2023 updated by: Jurriën M. ten Berg, MD, PhD, St. Antonius Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius Hospital
        • Contact:
          • Jurrien ten berg, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Severe or moderate aortic stenosis

Description

Inclusion Criteria:

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

No exclusion criteria are applicable to this registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)
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.
Until completion of the study (August 1, 2027)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z23.069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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