Future Optimal Research and Care Evaluation - Aortic Stenosis

Severe Aortic Valve Stenosis Clinical Trial

— FORCE-AoS  

Official title:

Future Optimal Research and Care Evaluation - Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168123
• Other study ID #: Z23.069
• Status: Recruiting
• Start date: November 27, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: December 2023
• Source: St. Antonius Hospital
• Contact: Christiaan Overduin
• Phone: +31 (0)88 320 0931
• Email: c.overduin[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2027
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Older than 18 years of age
• Severe or moderate aortic stenosis No exclusion criteria are applicable to this registry

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Mortality according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Neurological events according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Hospitalisation according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Bleeding and transfusions according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Vascular and access-related complications according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Cardiac structural complications according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Other procedural or valve-related complications according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	New conduction disturbances and arrhythmias according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Acute kidney injury according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Myocardial infarction according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Bioprosthetic valve dysfunction according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Leaflet thickening and reduced motion according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)
Secondary	Clinically significant valve thrombosis according the VARC-3 criteria	The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.	Until completion of the study (August 1, 2027)