Clinical trial NCT06168123: Future Optimal Research and Care Evaluation - Aortic Stenosis
Official title: Future Optimal Research and Care Evaluation - Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Aortic Valve Stenosis
Moderate Aortic Valve Stenosis
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe or moderate aortic stenosis

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.


Eligibility criteria: Inclusion Criteria:

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

No exclusion criteria are applicable to this registry

Primary outcomes:
measure: Quality of life as assessed by the EQ-5D-5L
timeFrame: Until completion of the study (August 1, 2027)
measure: Quality of life as assessed by the KCCQ
timeFrame: Until completion of the study (August 1, 2027)
measure: Quality of life as assessed by the SF-12
timeFrame: Until completion of the study (August 1, 2027)
Secondary outcomes:
measure: Mortality according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Neurological events according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Hospitalisation according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Bleeding and transfusions according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Vascular and access-related complications according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Cardiac structural complications according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Other procedural or valve-related complications according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: New conduction disturbances and arrhythmias according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Acute kidney injury according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Myocardial infarction according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Bioprosthetic valve dysfunction according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Leaflet thickening and reduced motion according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
measure: Clinically significant valve thrombosis according the VARC-3 criteria
timeFrame: Until completion of the study (August 1, 2027)
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
References: